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Administrative data

Description of key information

Chronic: Oral (similar to OECD 453), rat: NOAEL = 615 mg/kg bw; RA from CAS 16470-24-9
Correction for molecular weight: NOAEL (target substance) = 580 mg/kg bw

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
615 mg/kg bw/day
Study duration:
chronic
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

No data is available on repeated dose toxicity for the test substance. However, reliable data from a subacute and a chronic study performed with CAS 16470-24-9; a close structural analogue, is available.

 

Chronic treatment:

A chronic oral toxicity study performed according to a protocol equivalent to OECD TG 453 with CAS 16470-24-9 (88% pure) is available. The test substance was administered to 50 Wistar rats/sex/dose in diet at dose levels of 0, 100, 1000, and 10000 ppm for 24 months. There were no compound related effects in mortality, clinical signs, body weight, food consumption, haematology, clinical chemistry, urinalysis, organ weights, or gross and histologic pathology compared to controls. The study is well-documented and haematological and clinical chemistry parameters were evaluated after 1, 3, 6, 12 and 24 months. At the end of the study slight effect in organ weights could be observed (kidney, liver, lung, heart, and testes). Except for the kidney, there were no dose-relationship and the changes in kidney weight, although statistically significant, were below 10% and thus not considered toxicologically relevant. Based on feed intake, the NOAEL for females is 709 mg/kg bw/day and for males 521 mg/kg bw/day, both corresponding to the 10000 ppm, the highest dose in this study. The NOAEL for males and females is set to 615 mg/kg bw/day. Although only limited parameters were analysed compared to the actual guideline, this chronic study in the rat is considered reliable and suitable for assessment. No target organ could be identified (Bayer AG, 1978a).

As there is reliable data from a 2-year chronic study, additional data on subacute or subchronic treatment is not required.

Justification for classification or non-classification

The available data on repeated dose toxicity is reliable and suitable for classification. Based on this data, classification for specific organ toxicity after repeated exposure according to 67/584/EEC and EC/1272/2008 is not warranted.