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Administrative data

Description of key information

A 28-day toxicity study and a 90-day toxicity study with rats (oral administration via gavage) were performed. The NOAEL of the 90-day toxicity study for both sexes (316 mg per kg body weight and day) is used for the CSA.
28-day toxicity study according to OECD 407, EU method B.7
90-day toxicity study according to OECD 408, EU method B.26

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
316 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The test substance induced mild hepatic alterations, notable as hepatocellular vacuoles and by some clinical-chemical parameters.

A decrease in the number of platelets in the blood and some organ weight changes were noted in addition.

All test substance related findings were present only in a low grade of severity and never became life-threatening.

Changes in the high dosed group are interpreted as possibly adverse ones. In the mid and the low dosed group only the presence of hepatocellular vacuoles is attributed to the test substance, but, in the absence of clear signs of toxicity, they are interpreted rather as adaptive changes.

There was no pronounced sex difference in the response to the test substance.

None of the test substance related effects persisted until the end of the recovery period.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification

The No-observed-adverse-effect-level (NOAEL) of "Resin 835 A" was at 316 mg per kg body weight and day in both sexes, based on possible adverse effects in the high dosed group.

According to REGULATION (EC) No 1272/2008, the application of "STOT RE (H 372, H373)" is not considered as necessary for "Resin 835A", as no severe toxic effects were noted even at a dose of 1000 mg/kg.