Vinyl chloroacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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:

Vinyl chloroacetate

EC Number:

219-834-3

EC Name:

Vinyl chloroacetate

Cas Number:

2549-51-1

Molecular formula:

C4H5ClO2

IUPAC Name:

ethenyl 2-chloroacetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks.
- Weight at study initiation: Females: 202 - 226 g. Males: 221 - 247 g.
- Housing: Individually during the exposure then groups of five in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet N°1 (Special Diets Services Limited) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 10%
- Type of wrap if used: Surgical gauze with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with distilled water.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.67 mL/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity 30 min, 1h, 2h, and 4h after dosing and subsequently once daily. Individual bodyweights were recorded on Days 0, 7, and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed.

Clinical signs:

other: No signs of systemic toxicity were noted.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No signs of dermal irritation were noted during the study.

Any other information on results incl. tables

See 'attached background document'

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute toxicity study by dermal route was conducted on the registered substance according to the OECD Testing Guideline 402. The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008.

Executive summary:

The acute toxicity: dermal of the test substance was determined during a GLP study performed in accordance with the OECD Guideline for Testing of Chemicals 402.

Five male and five female Sprague-Dawley rats were exposed to 2000 mg/kg bw of the test substance for 24h. Clinical signs and body weight development were monitored for 14 days following the administration of the test substance. All animals were subjected to gross necropsy.

No deaths were observed. Dermal exposure to the test substance did not induce observable adverse effects.

The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008.