DfE Neurotoxicity


3.4 NEUROTOXICITY

 

Criteria

 

Chemicals that are considered neurotoxicants under GHS [15] (see GHS guidance values in Table 5) shall not pass the Criteria. Neurotoxicity is covered under Specific Target Organ Toxicity Repeated Exposure in GHS.

 

Table 5 – GHS Guidance Values

 

Route of Exposure

Guidance Value*

Oral (mg/kg-bw/day)

100

Dermal (mg/kg-bw/day)

200

Inhalation (gas) (ppm/6h/day)

250

Inhalation (vapor) (mg/L/6h/day)

1.0

Inhalation (dust/mist) (mg/L/6h/day)

0.2

*The doses provided are for 90-day studies. Guidance values are tripled for chemicals evaluated in 28-day studies.

 

 

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. 

 

Preferred Test Methods for GHS Review

 

 OECD Test Guideline 424: Neurotoxicity Study in Rodents [45] and

 OPPTS Harmonized Guideline 870.6200: Neurotoxicity screening battery [1].

 

Additional Test Methods for GHS Review

 

Additional evidence from OECD Test Guideline 426: Developmental Neurotoxicity Study [46] and OPPTS Harmonized Guideline: 870.6300 Developmental neurotoxicity study [47] can be used to screen chemicals for neurotoxicity.

 

Data Interpretation

 

 Section 3, Hazard Characterization in Guidelines for Neurotoxicity Risk Assessment [48], and

 GHS Ch. 3.9 Specific Target Organ Toxicity Repeated Exposure [49].

 





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