α-methylcyclohexylmethyl acetate

Endpoint summary

Description of key information

Acute oral toxicity: similar to OECD TG 401: LD50 8200 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-03-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is considered to be a reliability 2 since it predates GLP but is similar to OECD TG 401.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean weight males 222.5 g and females 217.5 g

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5010, 6310, 7940, and 10000 mg/kg bw

No. of animals per sex per dose:

5 animals per dose. 2 or 3 males or females per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, gross autopsy was performed.
- Body weights: Individual body weights were recorded before treatment.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

8 200 mg/kg bw

Based on:

test mat.

95% CL:

>= 7 300 - <= 9 270

Mortality:

5010 mg/kg: 0/3 males and 0/2 females
6310 mg/kg: 0/2 males and 1/3 females
7940 mg/kg: 0/3 males and 1/2 females
10000 mg/kg: 2/2 males and 3/3 females
Animals died within one to four days.

Clinical signs:

Reduced appetite and activity (one to four days in survivors), increasing weakness, ocular discharge, collapse, and death.

Gross pathology:

Hemorrhagic areas of the lungs, liver discoloration, and acute gastrointestinal inflammation. In the survivors (14-days) the viscera appeared normal.

Interpretation of results:

other: not classified

Remarks:

according to CLP Regulation (EC) 1272/2008

Conclusions:

The acute oral toxicity test showed a LD50 of 8200 mg/kg bw

Executive summary:

In the study which predated GLP and OECD guidelines, a single oral administration of 5010, 6310, 7940, and 10000 mg/kg bw test substance to a group of 5 rats (2 or 3 males and 2 or 3 females) was investigated for 14 days. Reduced appetite and activity (one to four days in survivors), increasing weakness, ocular discharge, collapse, and mortality were observed. At necropsy hemorrhagic areas of the lungs, liver discoloration, and acute gastrointestinal inflammation were observed. In the survivors (14-days) the viscera appeared normal. In the 5010, 6310, 7940, and 10000 mg/kg dose group, 0/5, 1/5, 1/5, and 5/5 animals died within one to four days, respectively. Under the conditions of the test the oral acute LD50 in rats was determined to be 8200 mg/kg (95% Confidence limits 7300 - 9270 mg/kg bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

In the study which predated GLP and OECD guidelines, a single oral administration of 5010, 6310, 7940, and 10000 mg/kg test substance to a group of 5 rats (2 or 3 males and 2 or 3 females) was investigated for 14 days. Reduced appetite and activity (one to four days in survivors), increasing weakness, ocular discharge, collapse, and mortality were observed. At necropsy hemorrhagic areas of the lungs, liver discoloration, and acute gastrointestinal inflammation were observed. In the survivors (14-days) the viscera appeared normal. In the 5010, 6310, 7940, and 10000 mg/kg dose group, 0/5, 1/5, 1/5, and 5/5 animals died within one to four days, respectively. Under the conditions of the test the oral acute LD50 in rats was determined to be 8200 mg/kg (95% Confidence limits 7300 - 9270 mg/kg bw).

Justification for classification or non-classification

According to the criteria outlined in Annex VI of 1272/2008/EC (CLP), the substance does not have to be classified as acute toxic by the oral route.