D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.

Endpoint summary

Description of key information

With regard to the acute toxicity of the registered substance, key studies for the oral and dermal exposure route are available. Using the acute toxic class method according OECD test TG 423, the LD50 cut-off value of Glucamide CC is 2500 mg/kg body weight. Intoxicated animals showed a consistent clinical picture pointing to an unspecific mode of action. The acute dermal toxicity of the registered substance was evaluated in an OECD 402 study according to GLP. After topical treatment with the limit dose of 2000 mg/kg body weight neither mortality nor significant clinical symptoms of intoxication were observed. The LD50 after dermal treatment was established to be greater 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Quality of whole database:

Data reliable and meet criteria for classification & labelling requirements.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute studies with Glucamide CC have revealed a low toxicity for all routes of exposure. Using the acute toxic class method according OECD test guideline 423, Glucamide CC exhibits low acute oral toxicity (CLP no category). The LD50 cut-off value following single oral application of Glucamide CC to rats via gavage is 2500 mg/kg body weight. Intoxicated animals showed a consistent clinical picture (e.g. reduced spontaneous activity, piloerection, prone or hunched position) pointing to an unspecific mode of action. All symptoms recovered within up to 3 days post-dose.Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain.

Data regarding acute oral toxicity are also available on the read-across compound Glucamide 24 (Test material E-4086.01, 45% active).In an OECD TG 401 (1987 study, Wistar rats were exposed via oral gavage to 900 mg a.i./kg bw (2000 mg test article/kg bw) or 2000 mg a.i./kg bw (4444 mg test article/kg bw). No deaths occurred in the study. Weight loss was observed in one female at the high dose on Days 8 – 15 and body weight gain was reduced in 2 high-dose and 1 low-dose females.At the lower dose, signs were observed in a few male rats which included slight sedation and slight ruffled fur; in the high dose group, slightly ruffled fur was observed in two animals of each sex. The acute oral LD50 was concluded to be greater than 2000 mg Glucamide/kg body weight

With regard to acute systemic dermal toxicity, single administration of 2000 mg/kg body weight to rats according OECD test guideline 402 was not associated with mortality or with any clinical signs of toxicity. However, reversible signs of dermal irritation were observed at the treated skin sites. The LD50 of Glucamide CC in rats is thus greater 2000 mg/kg body weight.The read-across compound, Glucamide 24 (Test material, E-4194.01, 98.8%, also has low acute toxicity via the dermal route and thus support a.m. conclusion. Testing in male and female New Zealand White rabbits using EEC Methods Directive 84/449/EEC, Part B, Method B3 (1984) indicated a comparable LD50 of greater 2000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.

Justification for selection of acute toxicity – dermal endpoint
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.

Justification for classification or non-classification

Based on the results from an OECD TG 423 guideline study which revealed a LD50 cut-off value of 2500 mg/kg body weight, no classification according to CLP of Glucamide CC is warranted with regard to acute oral toxicity.

Based on the results from an OECD 402 guideline study which revealed a LD50 greater 2000 mg/kg body weight, no classification of Glucamide CC according to CLP is warranted with regard to acute dermal toxicity.