tert-butyl methacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-09-14 until 2006-09-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

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 No.: 0481076
- Purity: 99.9%
- Known impurities: H2O 0.009 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Cr!: CD® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: >= 200 g
- Housing: suspended solid-floor polypropylene cages furnished within woodflakes; single housing during exposure, group housing (up to 4/sex) during the observation period
- Historical data:
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK , ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25°C
- Humidity: 30 - 70 %
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours of artificial light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 %
- Type of wrap if used: surgical gauze, semi-occluded with self-adhesie bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with cotton woll moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.29 mL/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2 and 4 h after dosing and daily thereafter, body weights on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: dermal irritation according to Draize (1977)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No adverse effects noted

Mortality:

No mortality was observed.

Clinical signs:

other: There were no signs of systemic reaction to treatment. There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted.

Other findings:

none

Any other information on results incl. tables

No signs of dermal irritation were detected during the 14 post-exposure period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test material In the rat was found to be greater than 2000 mg/kg body weight under the conditions of the present study.

Executive summary:

A GLP-compliant acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat was conducted according to OECD guideline 402 and EU method B3. A total of 10 animals (5 males and 5 females) were given a single, 24-hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs, bodyweight development, and dermal irritation were monitored during the study. All animals were subjected to gross necropsy. At each observation time point and following necropsy, there were no signs of dermal irritation or systemic toxicity. All animals showed expected gains in body weight over the study period. The acute LD50 of the test material In the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.