3,3,5-trimethylcyclohexyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January-February 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3,5-trimethylcyclohexyl methacrylate

EC Number:

231-927-0

EC Name:

3,3,5-trimethylcyclohexyl methacrylate

Cas Number:

7779-31-9

Molecular formula:

C13H22O2

IUPAC Name:

3,3,5-trimethylcyclohexyl 2-methylprop-2-enoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males = 173-256g ; females = 150-164g
- Fasting period before study: yes (12/18 hours)
- Housing: by group of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The test article was placed into a glass beaker on a tared balance and the vehicle (PEG400) was added. A weight by weight susmension was prepared using a homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment using the magentic stirrer.
The animals received the test article on a mg/.kg bw based by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted). Food was again presented approximately one hour after dosing.
Volumes of administration : 10 ml (1000 mg/kg), 20 ml (5000 mg/kg).

Doses:

1000 and 5000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:Viability was confirmed and recorded four times during test day 1 and daily days 2-15. each animal had an examination for changes in appearance and behavior four times during day 1, and daily during days 2-15.
- Frequency of weighing: on test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes

Statistics:

no

Results and discussion

Preliminary study:

no

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed over a period of 15 days after the single administration.

Clinical signs:

other: sedation, dyspnea, curved body position and ruffled fur were observed in animals exposed to 1000 and 5000 mg/kg. The symptoms were more pronounced in the higher dose group. All animals recovered within 6 to 7 observation days.

Gross pathology:

At the necropsy, reddish testes were observed in one male rat of the 5000 mg/kg group. No other macroscopic organ changes were observed.

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion , the acute oral LD0 of 3,3,5 -trimethylcyclohexylmethacrylate was estimated to be higher than 5000 mg/kg in rat.

Executive summary:

The test article 3,3,5 -trimethylcyclohexylmethacrylate was administered to rats of both sexes by oral gavage, at doses from 1000 and 5000 mg/kg.

No mortality was observed over a period of 15 days after the single administration. However, sedation, dyspnea, curved body position and ruffled fur were observed in animals exposed to 1000 and 5000 mg/kg. The symptoms were more pronounced in the higher dose group. All animals recovered within 6 to 7 observation days. At the necropsy, reddish testes were observed in one male rat of the 5000 mg/kg group. No other macroscopic organ changes were observed.

In conclusion , the acute oral LD0 of 3,3,5 -trimethylcyclohexylmethacrylate was estimated to be higher than 5000 mg/kg in rat.