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Description of key information

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
1 000 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

A 28-day repeated dose oral (gavage) toxicity study in the rat (OECD 407) was performed with FAT 41030 a structural analogue of FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of this study for read-across and as an additional back-up for non-classification of FAT41045 regarding acute toxicity is considered to be appropriate.

In the above subacute toxicity study, FAT 41030 was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. A control group was treated similarly with the vehicle, PEG 300, only. The groups comprised 5 animals per sex which were sacrificed after 28 days of treatment. Additional 5 rats per sex and group were used at 0 and 1000 mg/kg. These animals were treated for 28 days and then allowed a 14-day treatment-free recovery period after which they were sacrificed. Oral administration of FAT 41030 to Wistar rats at doses of 50, 200 and 1000 mg/kg/day, for 28 days was generally well tolerated and did neither produce early mortality or treatment-related signs of toxicological relevance (daily, weekly or functional observational battery) nor effects upon fore- and hindlimb grip strength or locomotor activity. Furthermore, this test revealed no effects on food consumption and body weight development, and there were no treatment-related changes in hematology parameters and no macroscopical and microscopical findings related to the administration of the test item. Test item-related findings were generally restricted to dark-red discoloration of feces and bedding in males and females treated with 50, 200, and 1000 mg/kg/day, to discolorations present in the jejunum of one male and the ileum and caecum of four males and the caecum of three females treated with 1000 mg/kg/day. These discolorations were considered to be a passive effect of the dyestuff rather than a sign of systemic toxicity and in the absence of physiological or histopathological findings considered to be of no toxicological relevance. Based on the results of this study, 50 mg/kg body weight/day of FAT 41030 was established as the no-observed-effect-level (NOEL) and 1000 mg/kg body weight/day of FAT 41030 as the no-observed-adverse-effect-level (NOAEL).


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
guidance test with GLP compliance

Justification for classification or non-classification

The above study results do not necessitate classification of FAT 41030 or FAT 41045 regarding acute or repeated dose toxicity according to the CLP (Reg. 1272/2008) or DSD (Dir. 67/548/EEC) regulations.