tert-butyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-01-20 to 1994-02-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference 1

Reference Type:

other company data

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1992

Deviations:

yes

Remarks:

modified according to the acute toxic class method (1992)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl methacrylate

EC Number:

209-548-7

EC Name:

tert-butyl methacrylate

Cas Number:

585-07-9

Molecular formula:

C8H14O2

IUPAC Name:

tert-butyl 2-methylprop-2-enoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot number of test material: 387
- Purity: 99.9%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator, exclusion of light
- the test substance was stable of the study period (study amendment information)

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- solution in vehicle

Test animals

Species:

rat

Strain:

Wistar

Remarks:

CHBB: THOM (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach, D
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adult
- Weight at study initiation: 150 - 300 g (+-20% of the mean weight)
- Fasting period before study: at least 16 h
- Housing: single housing
- Historical data: not specified
- Diet: Kliba Labordiaet 343, Klingenthalmuehle AG, Kauseraugst, CH; ad libitum
- Water: municipal drinking water; ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): yes (undefined)
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- olive oil DAB10
- Concentration in vehicle: 10 g/ 100 mL
- Justification for choice of vehicle: poor solubility of the test substance in water

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the pysical and chemical properties of the test substance and the composition, no pronounced acute oral toxicity was expected and a dose of 2000 mg/kg bw was tested (first in females afterwards in males).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration, at least once each workday
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (at least once a workday), body weight (before application, weekly thereafter and at the end of the study)

Results and discussion

Preliminary study:

no

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: males: no abnormalities females: abnormalities directly after exposure (hour 0); all animals showed a poor general state, piloerection, staggering; one animal showed a poor general state, apathy, and tremor; all symptoms were reversible within at least

Gross pathology:

no pathological findings observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this acute oral gavage study in male and female rats a LD50 > 2000 mg/kg bw was derived.

Executive summary:

A GLP conform study was performed to assess the range of mortality following oral administration of the test material as a solution in olive oil to Wistar rats. The study procedure was based on the EU method guideline B.1 and modified according to the acute toxic class method. A group of 6 fasted animals (3 males and 3 females) was given a single oral dose of 2000 mg/kg body weight. Signs of toxicity noted in the female animals comprised impaired or poor general state, dyspnoea, apathy, staggering and tremor. These symptoms are considered to be unspecific and disapperead within 2 days after exposure. The expected body weight gain has been observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the range of mortality after oral application was found to be greater than 2000 mg/kg body weight for male and female animals.