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Diss Factsheets

Administrative data

Description of key information

Only one study is available (BASF SE, 1999; Study report number 31S0269/98053) performed according to the OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
100 mg/kg bw/day

Additional information

In the OECD guideline 407 study S-MOIPA was administered to groups of 5 male and 5 female Wistar rats by gavage for 4 weeks at doses of 0, 30, 100 and 300 mg/kg body weight/day. The vehicle used was aqua bidest and the administration volume was 10 ml/kg from day 0 to 14, and 20 ml/kg from day 15 to day 27. Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. Additionally, general clinical observations were carried out before daily treatment, less than 1 hour after treatment and between 3 and 4 hours after treatment. Detailed clinical observations in an open field were conducted prior to the start of the administration period and weekly thereafter. Functional observational batteries (FOBs) and motor activity measurements were carried out after 4 weeks of treatment. Clinicochemical, hematological examinations and urinalyses were carried out towards the end of the administration period. All animals were assessed by gross pathology, followed by histopathological examinations.

The following substance-related effects were obtained:

- 300 mg/kg body weight: One female died on day 12; Abnormal clinical signs were observed on different days of the study such as reddish smeared snout region or red smeared nose, urine smeared anogenital region, salivation after treatment, respiratory sounds, abdominal respiration, labored respiration, and/or piloerection.

- 100 mg/kg body weight: No substance-related effects

- 30 mg/kg body weight: No substance-related effects

Thus, toxic effects were seen at the high dose level, only. These findings were most probably related to a local affection of the upper digestive tract and/or general toxicity. The no observed adverse effect level (NOAEL) under the conditions of this study was 100 mg/kg for both sexes.

The substance causes burns. Therefore, local effects seem to be the dominant toxicological effects.

Justification for classification or non-classification