Acute Toxicity Estimates

The acute toxicity estimate ( ATE - Acute Toxicity Estimates ) is used for defining and calculation in the risk categories and classes of risk of acute toxicity after GHS / CLP . The basis for the ATE value is the use of known LD ₅₀ or LC ₅₀ values and a corresponding conversion.

The ATE value can be used to better communicate the properties of acute toxicity, for example within a supply chain .

The ATE represents an estimate and is not a test result.

Determination of the ATE value for pure substances

If acute toxicity is known

If the acute toxicity is known in accordance with the GHS or CLP criteria (e.g. from test results), an estimate is made based on an assessment of the available data using scientific expertise (Regulation (EC) No. 1272/2008 of the European Parliament and the council on the classification, labeling and packaging of substances and mixtures, Art. 5 in conjunction with Annex I, Section 3.1.2.2.1). The user can therefore choose from several test results or summarize them in an evaluation. A possible minimum or legal classification of a substance must be taken into account as an additional boundary condition.

The definition of the acute toxicity category is based on the ATE value according to the following table:

Route of exposure	Category 1	Category 2	Category 3	Category 4	Category 5 only GHS
oral (mg / kg body weight)	ATE ≤ 5	5 <ATE ≤ 50	50 <ATE ≤ 300	300 <ATE ≤ 2000	2000 <ATE ≤ 5000
dermal (mg / kg body weight)	ATE ≤ 50	50 <ATE ≤ 200	200 <ATE ≤ 1000	1000 <ATE ≤ 2000	2000 <ATE ≤ 5000
Gases (ppmV)	ATE ≤ 100	100 <ATE ≤ 500	500 <ATE ≤ 2500	2500 <ATE ≤ 20000
Vapors (mg / l)	ATE ≤ 0.5	0.5 <ATE ≤ 2	2 <ATE ≤ 10	10 <ATE ≤ 20
Dusts and mists (mg / l)	ATE ≤ 0.05	0.05 <ATE ≤ 0.5	0.5 <ATE ≤ 1	1 <ATE ≤ 5

Substances to which a hazard category has already been assigned by legal or minimum classification can only be assigned an estimated value of acute toxicity, which is within the specifications of table 3.1.1. lies.

The classification in hazard category 5 is mainly based on extrapolation , estimation, experience and expert judgment. It is not recommended to conduct animal testing in this area.

If the hazard category is known

If only the hazard category for a substance is known, but no precise values for acute toxicity (e.g. test results), the following ATE values are used to calculate the classification of a mixture.

Route of exposure	Category 1	Category 2	Category 3	Category 4	Category 5 only GHS
oral (mg / kg body weight)	ATE = 0.5	ATE = 5	ATE = 100	ATE = 500	ATE = 2500
dermal (mg / kg body weight)	ATE = 5	ATE = 50	ATE = 300	ATE = 1100	ATE = 2500
Gases (ppmV)	ATE = 10	ATE = 100	ATE = 700	ATE = 4500
Vapors (mg / l)	ATE = 0.05	ATE = 0.5	ATE = 3	ATE = 11
Dusts and mists (mg / l)	ATE = 0.005	ATE = 0.05	ATE = 0.5	ATE = 1.5

These ATE values do not represent test results and are only equivalent to them to a limited extent.

Calculation of the ATE value of mixtures

The ATE value of a mixture can be calculated from the ATE values of its components. Let be the number of toxically relevant components, of which the number with a known ATE value and the number with an unknown ATE value. Furthermore, let the concentrations of the constituents with the respective known ATE values and the concentrations of the constituents with unknown ATE values be assumed. The concentrations are to be given as percent by mass (% w / w) or percent by volume (% v / v). If the total concentration of the constituents for which there is no information on their acute toxicity in a mixture is not greater than ten percent, i.e. ${\ displaystyle \ mathrm {ATE} _ {\ mathrm {mix}}}$ ${\ displaystyle N = n + m}$ ${\ displaystyle n}$ ${\ displaystyle m}$ ${\ displaystyle C_ {1} \ ldots C_ {n}}$ ${\ displaystyle \ mathrm {ATE} _ {1} \ ldots \ mathrm {ATE} _ {n}}$ ${\ displaystyle C_ {n + 1} \ ldots C_ {N}}$ ${\ displaystyle C_ {i}}$

{\ displaystyle \ sum _ {i = n + 1} ^ {N} C_ {i} \ leq 10 \, \%}

The following formula applies to the ATE value of the mixture:

{\ displaystyle {\ frac {100 \, \%} {\ mathrm {ATE} _ {\ mathrm {mix}}}} = \ sum _ {i = 1} ^ {n} {\ frac {C_ {i} } {\ mathrm {ATE} _ {i}}}}

.

If the total concentration of the components of unknown acute toxicity in a mixture is greater than ten percent, i.e.

{\ displaystyle \ sum _ {i = n + 1} ^ {N} C_ {i}> 10 \, \%}

use the following formula:

{\ displaystyle {\ frac {100 \, \% - \ sum _ {i = n + 1} ^ {N} C_ {i}} {\ mathrm {ATE} _ {\ mathrm {mix}}}} = \ sum _ {i = 1} ^ {n} {\ frac {C_ {i}} {\ mathrm {ATE} _ {i}}}}

.

Individual evidence

↑ CLP regulation. Part 3. 3.1.2
↑ Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on the classification, labeling and packaging of substances and mixtures, consolidated version , Annex I, Para. 3.1.2. Table 3.1.1.
↑ This column is in Table 3.1.1. from appendix I par. 3.1.2. of Regulation No. 1272/2008 / EEC is not included, since the hazard characteristic "acute toxic category 5" was not recorded in the legal classification system of CLP.
↑ GHS, Part 3, Table 3.1.1.
↑ ^a ^b Guidance on the Application of the CLP Criteria. P. 19 , accessed on May 23, 2018 .

Web links

Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fourth revised edition 2011, Part 3 (PDF; 773 kB)

[1] CLP regulation. Part 3. 3.1.2

[2] Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on the classification, labeling and packaging of substances and mixtures, consolidated version , Annex I, Para. 3.1.2. Table 3.1.1.

[3] This column is in Table 3.1.1. from appendix I par. 3.1.2. of Regulation No. 1272/2008 / EEC is not included, since the hazard characteristic "acute toxic category 5" was not recorded in the legal classification system of CLP.

[4] GHS, Part 3, Table 3.1.1.

[encha-5] Guidance on the Application of the CLP Criteria. P. 19 , accessed on May 23, 2018 .