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Administrative data

Description of key information

NOAEL sub-acute (rat): 1000 mg/Kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
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

The 28 days study, performed on a Similar substance 01 and used in Read Across, followed the EU B.7 Guideline Repeated Dose (28 days) Toxicity (oral) and the OECD 407 Guideline, Repeated Dose 28 day Oral Toxicity Study in Rodents.

Based on the results of a 5 day range finding study, the dose levels for the 28 day toxicity study were selected to be 0, 50, 150 and 1000 mgl kg/day.

Treatment-related findings observed were as follows:

50 mg/kg/day:-No treatment-related findings.

150 mg/kg/day:- No treatment-related findings.

1000 mg/kg/day: No treatment-related findings.

From the results presented in this report a No Observed Adverse Effect Level (NOAEL) of 1000mg kg/day was established.

Based on the read-across principle (read-across from supporting substance -structural analogue or surrogate), the results can be considered for the repeated dose toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.

Justification for classification or non-classification

According to the CLP Annex 1: 3.9.2.8: effects considered not to support classification for specific target organ toxicity following repeated exposure are: small changes in clinical biochemistry, haematology or urinalysis parameters and/or transient effects, when such changes or effects are of doubtful or minimal toxicological importance.

28 days repeated oral administration to rats by gavage at the dose levels 50, 150 and 1000 mg/kg/day did not cause mortality. 

No Observed Adverse Effect Level (NOAEL) of 1000mg kg/day was established.

Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), the result can be considered for the repeated dose toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.

As conclusion the registered substance is not classified for the oral repeated dose toxicity, according to CLP Regulation 1272/2008.