C12-14 (even numbered) alkyl glycosides, oligomeric and C12-14 (even numbered) alkyl glycosides, oligomeric, carboxymethyl ethers, sodium salts

Endpoint summary

Description of key information

Under the experimental conditions, the oral LD50 of the test item was found to be greater than 2000 mg/kg ww in rats

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

The acute oral toxicity in rats was determined according the method recommanded in the OECD Guideline No. 423, "Acute Oral Toxicity - ACUTE TOXIC CLASS METHOD", 22nd March 1996, and the EU-Guideline B.1 "Acute Toxicity(Oral) - ACUTE TOXIC CLASS METHOD", January 1997.

The study was carried out with one group consisting of three male and three female animals given a dose of 2000 mg/kg bw. The following clinical signs were observed:

Females: Animals No. 1, No. 2 and No. 3 showed piloerection 1,3 and 6 hours after the application of the test article. From Day 1 until the end of the observation period on Day 14 no abnormalities were revealed in the three rats.

Males: Animals No. 4, No. 5 and No. 6 showed a pinched abdomen and piloerection 1 hour after the application of the test article. After 3 and 6 hours piloerection was still observed. From Day 1 until the end of the observation period on Day 14 no abnormalities were revealed.

Necropsy: The gross necropsy of the female and male animals revealed no pathological abnormalities.

Conclusion: Under the the experimental conditions described in this study, the oral LD50 of the test item in rats was found to be above 2000 mg/kg bw.

In an acute dermal toxicity study (OECD 402 Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item D-Glucopyranose, 6-O-(carboxymethyl)-, Oligomer, C12-14-alkyl glycosidet, sodium salt to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. · No mortality occurred · No clinical findings were observed · The following test item-related local effects were recorded during the course of the study: Erythema grade 1 to 4, Edema grade 1 to 4, Incrustations, Incrustations partly detached, Scaling · The mean body weight of the animals increased within the normal range throughout the study period. · No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw

Justification for selection of acute toxicity – dermal endpoint
Klimisch 1 study

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.