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Description of key information

PR 112


The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.


PR022


A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no 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 (further information necessary)

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

No Classification, as no adverse effects observed.

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