Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study following a method equivalent to a recognised guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

The principles of the method were in accordance with the US 16 CFR 1500.3 definitions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

EC Number:

248-792-9

EC Name:

Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Cas Number:

28043-10-9

Molecular formula:

C11H18O2

IUPAC Name:

methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Not reported.
- Weight at study initiation: 200 - 300 g
- Fasting period before study: Overnight.
- Housing: Not reported but in compliance with Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3 (USA).
- Diet: rat chow ad libitum
- Water: ad libitum
- Acclimation period: Not reported.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was given orally by syringe and dosing needle. The sample was dosed as supplied.

Doses:

2000, 2510, 3160, 3980, 5000 and 6310 mg/kg bw

No. of animals per sex per dose:

Six groups of 10: 5 per sex per dose; 10 total per dose level.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Within first six hours and observations daily for 14 days; body weights before dose and at end of observation period
- Necropsy of survivors performed: Yes.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

4 200 mg/kg bw

Based on:

test mat.

95% CL:

3 700 - 4 900

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4 100 mg/kg bw

Based on:

test mat.

95% CL:

3 300 - 4 900

Mortality:

2000 mg/kg bw: No mortalities
2510 mg/kg bw: No mortalities
3160 mg/kg bw: 1 female mortality
3980mg/kg bw: 2 male and 2 female mortalities
5000 mg/kg bw: 4 male and 4 female mortalities
6310 mg/kg bw: Complete mortality.

Clinical signs:

other: 3160 mg/kg bw: slightly depressed and ruffled after 2 hours. They appeared essentially normal within 24 hours. 3980 mg/kg bw: depressed, ruffled, drooling and dirty after 2-4 hours. They were severely depressed after 6 hours. The surviving animals were in

Gross pathology:

No significant findings on necropsy were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the LD50 was determined to be 4100 mg/kg bw in male/female wistar rats.

Executive summary:

The GLP study was performed following a method similar to OECD TG 401 to assess the acute oral toxicity potential of the test substance to male/female Wistar rats. The test material was administered as a single oral dose to groups of 5 male and 5 female rats orally, at several dose levels of 2000, 2510, 3160, 3980, 5000 and 6310 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. Animals were examined for gross pathology. At 2000 mg/kg bw there was no mortality and no significant systemic toxicity. No remarkable findings were noted on necropsy. Under the conditions of this study the LD50 was determined to be 4100 mg/kg bw (female; C.I. = 3300 - 4900) and 4200 mg/kg bw (male; C.I. = 3700 - 4900).