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Endpoint summary

Description of key information

NOAEL >=1000 mg/kg bw/day (subacute rat)

Additional information

Repeated dose toxicity, oral:

In a 28-d oral toxicity study in the rat (doses: 0, 100, 300 and 1000 mg/kg bw/d orally by gavage; vehicle: peanut oil), a NOAEL of ≥1,000 mg/kg bw d was derived. Oral treatment with 1,000 mg/kg bw /d for 28 days led to salivation in males and females during the treatment and on the first day of the recovery period. This effect is considered to be a test-item related sign of discomfort and not an adverse effect.

There were no effects on body weight and food consumption as well as on locomotor activity. Macroscopic post mortem examinations, clinical biochemistry and haematology revealed no test item related changes in the treated animals. None of the rats died prematurely.

Repeated dose toxicity, inhalation:

According to regulation (EC) 1907/2006 Annex XI (weight of evidence), testing for sub-chronic inhalation toxicity is not considered to be required, for the following reasons:

- Repeated dose toxicity study via inhalation route does not need to be performed since based on the low mobility and the negligible volatility, the test material “SymMollient® S” can safely be assumed to have a very low potential for human inhalation hazard during handling or application.

-The substance is a pasty solid at 20°C with a melting point of 22°C at atmospheric pressure and is not a powder with an inhalable size.

Repeated dose toxicity, dermal:

According to regulation (EC) 1907/2006 Annex XI (weight of evidence), testing for sub-chronic dermal toxicity is not considered to be required, for the following reasons:

- Due to the low water solubility (A: 3.5 µg/L/ B: 1.7 µg/L) and the high lipophilicity (logPow (calculated) = 11.2 / 12.2), quantitatively relevant dermal absorption cannot completely ruled out based on theoretical considerations only. However, the dermal bioavailability is considered unlikely to be higher than the oral bioavailability.

- In accordance with ECHA guidance on information requirements and chemical safety assessment-chapter R.8: characterisation of dose [concentration]-response for human health, May 2008, a DNEL for systemic effects could be derived by route-to-route extrapolation from a 28-day oral toxicity study in rats with SymMollient® S.

Justification for classification or non-classification

No classification and labelling of SymMollient® S according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – repeated exposure, oral is necessary, since the guidance value for a Category 1 classification of C<30 mg test substance/kg bw/day (based on sub-acute toxicity study), and the guidance value for a Category 2 classification of 30 <C<300 mg test substance/kg bw/day (based on sub-acute toxicity study) are not met. The NOAEL is derived at ≥1,000 mg/kg bw/d.

Furthermore, no classification and labelling according to regulation (EC) 1272/2008 are expected for long term oral, dermal and inhalation are expected.