Registration Dossier

Administrative data

Description of key information

Not harmful/toxic for repeated dose exposure

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 250 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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

According to the CLP Regulation (EC n. 1272/2008), 3.9 Specific target organ toxicity - repeated exposure section, substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement, on the basis of the weight of all evidence available, including the use of recommended guidance values which take into account the duration of exposure and the dose/concentration which produced the effect(s), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed.

 

In order to help reach a decision about whether a substance shall be classified or not, and to what degree it shall be classified (Category 1 or Category 2), dose/concentration ‘guidance values’ are provided for consideration of the dose/concentration which has been shown to produce significant health effects. The guidance values refer to effects seen in a standard 90-day toxicity study conducted in rats.

According to the CLP Regulation (EC n. 1272/2008) Table 3.9.3, a substance has to be classified as Category 2 when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals by oral route, are seen to occur below the trigger value of 100 mg/kg bw/day.

In the case of the target substance, no statistically significant effects were recorded on RA Substance 1 and RA Substance 2 up to 1250 mg/kg bw/day in females and males rats and treated for 13 weeks. Taken into account the reference values indicated in the CLP Regulation, the substance effects were recorded at doses exceeding of the classification criteria.

In conclusion, the substance is expected to be not classified for repeated dose toxicity according to the CLP Regulation (EC n. 1272/2008).