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Administrative data

Description of key information

Under the test conditions the test item showed a no-observed-adverse-effect level (NOAEL) of greater than 1000 mg/kg bw/day for systemic changes.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The test item was investigated for repeated dose toxicity in a 90 days oral gavage study in rats according to OECD guideline 408 and EU method B.26. 40 male and 40 female CD/Crl:CD rats in groups of ten animals per sex and per group were given 0, 100, 300 and 1000 mg/kg bw/day of the test item. The test item was dissolved in tap water; the test item was administered orally by gavage once daily in a volume of 5 mL/kg bw/day for 90 days. At the end of the study, the animals were saccrificed and examined for gross pathology and histopathology.

No test item related mortality occurred.

Rats treated with 100, 300 or 1000 mg/kg bw/day of the test item did not reveal any influence on the behaviour or external appearance as well as the parameters of functional observations.

No influence was noted on the body weight, body weight gain, the body weight at autopsy, food and drinking water consumption, haematological parameters as well as for the biochemical parameters in female animals.

A slightly reduced bilirubin plasma level was noted for the male rats treated with the high dose of 1000 mg/kg bw/day of the test item.

No test item related influence was noted on the urinary parameters, the eyes, or optic region and the auditory acuity at any of the tested dose levels.

Relative and absolute uterus weights were slightly (statistically not relevant) increased for the females at 1000 mg/kg bw/day of the test item. No histopathological correlate was was noted for the increased uterus weights.

The histopathological examination revealed an increased severity in the degree of swollen gastric chief cells in the pars glandularis of the stomach of the male animals treated with 1000 mg/kg bw/day of the test item.

Under the test conditions, the no-observed effect level (NOEL) was 300 mg/kg bw/day of the test item for systemic changes.

Under the test conditions, the no-observed adverse-effect level (NOAEL) was greater than 1000 mg/kg bw/day of test item for systemic changes.

This test result is supported by the result obtained in a 90 day study with Alkyl Polyglucoside. In a oral 90-day toxicity study with C12 -14 alkyl glycosides Sprague-Dawley rats received doses of 0, 250, 500 and 1000 mg/kg/day in water by gavage. This study identified a NOAEL at the highest dose level of 1000 mg/kg/day because the only effects seen were due to the irritating potential of the test compound administered as bolus.

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.