Benzene, 1-chloro-2,3-dimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 17 Dec 2003 to 31 Dec 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-880-4

EC Name:

-

Cas Number:

608-23-1

Molecular formula:

C8H9Cl

IUPAC Name:

1-chloro-2,3-dimethylbenzene

Test material form:

liquid

Details on test material:

- Density: 1.05 g/cm3

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12-15 weeks
- Weight at study initiation: 2.00-2.36 kg
- Fasting period before study: no
- Housing: individually
- Diet: TEK 8630 Rabbit Diet, Harlan Teklad, Madison, WI, USA, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10 % of body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with USP water for injection
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: frequently during the first day, careful clinical observations at least once daily; weighing: days 0, 7 and 14
- Necropsy of survivors performed: Yes

Statistics:

not performed

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 effects

Clinical signs:

other: No effects

Gross pathology:

No effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the dermal LD50 in rabbits was > 2000 mg/kg bw.

Executive summary:

The test substance, 1-chloro-2,3-dimethylbenzene, was evaluated for its potential to produce systemic toxicity or death after a single topical 24-hour application to the skin of albino rabbits at a dose of 2000 mg/kg bw. No animal died during the course of the study, therefore the test substance is considered non-toxic according to the criteria of the study protocol.