Registration Dossier

Administrative data

Description of key information

Repeat Dose Oral Toxicity: NOAEL = 50 mg/Kg bw/day (Rat)

Repeat Dose Inhalation Toxicity: waiving

Repeat Dose Dermal Toxicity: waiving

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One key Guideline (OECD 422) combined repeated dose, reproductive developmental toxicity screening study in rats available for assessment.
System:
gastrointestinal tract
Organ:
stomach
thymus

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Toxicity was observed in a rat OECD 422 study occurring above the guidance value (≥ 100 mg/kg bw/day) by the oral route. According to the ECHA Guidance on the Application of the CLP Criteria “Haber’s rule is used to adjust the standard guidance values, which are for studies of 90-day duration, for studies of longer or shorter durations.” In this case, the OECD 422 is used as Guideline for the repeated dose testing by oral route. The animals were tested for 54 days () and 41 days (). Based on this testing period, the thresholds for classification, considering Habers rule, are 166 mg/Kg bw/day for female and 219 mg/Kg bw/day for male. Based on the results of the study, the LOAEL correspond to 300 mg/Kg bw/day, therefore the test material is not classified for specific target organ toxicity after repeated exposure according to CLP Regulation (EC 1272/2008), section 3.9.