Reaction mass of cis-1-methyl-1-(4-methylcyclohexyl) ethyl acetate and trans-1-methyl-1-(4-methylcyclohexyl) ethyl acetate and cis- 4-isopropyl-1-methylcyclohexyl acetate and trans-4-isopropyl-1-methylcyclohexyl acetate

Endpoint summary

Description of key information

In an acute oral toxicity study performed according to OECD guideline 423 and GLP compliant, LD50 > 2000 mg/kg bw
In an acute dermal toxicity limit test performed according to OECD guideline 402 and GLP compliant, LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Study performed according to OECD guideline 423 and GLP compliant.

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

Quality of whole database:

Study performed according to OECD guideline 402 and GLP compliant.

Additional information

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 Sprague Dawley female rats were given a single oral (gavage) dose of Menthanyl acetate multiconstituent at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. No mortality and no clinical signs were observed. Body weight gain of the treated animals was not affected by test item. No macroscopic abnormalities were observed at necropsy. In this study, the oral LD50 of Menthanyl acetate multiconstituent was considered to be higher than 2000 mg/kg bw in female rats.

In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, Sprague Dawley rats (5/sex/dose) were given a single dermal application of Menthanyl acetate multiconstituent at 2000 mg/kg bw. The test item was placed directly on dorsal area of the skin representing approximately 10 % of the total body surface of the animals. The application site was then covered with a semiocclusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. No mortality and no clinical signs were observed during the study. Body weight gain of the treated animals was not affected by test item. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 of Menthanyl acetate multiconstituent was considered to be higher than 2000 mg/kg bw in rats.

Justification for selection of acute toxicity – oral endpoint
Only one study available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint
No study was available and it was not necessary to provide one because acute toxicity is already assessed via two different routes of exposure. Acute toxicity studies by oral and dermal routes showed very low toxicity, with high LD50 values.

Justification for selection of acute toxicity – dermal endpoint
Only one study available for this endpoint

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in rats therefore Menthanyl acetate multiconstituent does not need to be classified for acute toxicity according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (1272/2008).