DfE Acute Mammalian Toxicity


3.1 ACUTE MAMMALIAN TOXICITY

 

Criteria

 

Applying GHS criteria, a chemical shall not have a median lethal dose or concentration less than or equal to those values listed in Table 1. For inhalation studies, exposure duration should be at least four hours; the thresholds for inhalation are the same for exposures greater than four hours. Exposures of less than four hours will be evaluated on a case-by-case basis. 

 

Table 1 – GHS Thresholds

 

Route of Exposure

Median Lethal Dose/Concentration

Oral LD50 (mg/kg bw)

2000

Dermal LD50 (mg/kg bw)

2000

Inhalation, gas LC50 (ppmV)

5000

Inhalation, vapor LC50 (mg/L)

20

Inhalation, dust/mist/fumes LC50 (mg/L)

5

 
 

 

Additionally, a chemical does not pass the Criteria if it carries one of the following EU Risk Phrases, which align with GHS thresholds:

 

 Table 2 – Acute Toxicity Risk Phrases

 

R20

Harmful by inhalation

R21

Harmful in contact with skin

R22

Harmful if swallowed

R23

Toxic by inhalation

R24

Toxic in contact with skin

R25

Toxic if swallowed

R26

Very toxic by inhalation

R27

Very toxic in contact with skin

R28

Very toxic if swallowed

And all combination risk phrases containing one or more of the above.

 
 
 

Data Requirements

 

All available data, measured and/or estimated, for the chemical and/or a suitable analog will be reviewed against the criteria using a weight-of-evidence approach.

Test Methods for GHS Review

 OPPTS Harmonized Guideline 870.1100: Acute oral toxicity [6];

 OPPTS Harmonized Guideline 870.1200: Acute dermal toxicity [7]

 OPPTS Harmonized Guideline 870.1300: Acute inhalation toxicity [8];

 OECD Test Guideline 420: Acute Oral Toxicity-Fixed Dose Method [9];

 OECD Test Guideline 423: Acute Oral Toxicity – Acute Toxic Class Method [10];

 OECD Test Guideline 425: Acute Oral Toxicity – Up-and-Down Procedure [11];

 OECD Test Guideline 402: Acute Dermal Toxicity [12]; and

 OECD Test Guideline 403: Acute Inhalation Toxicity [13].

 

Data Interpretation

 

 For additional information, see GHS Ch 3.1 Acute Toxicity [14].

 
 
 
 


 



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