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Toxicological information

Acute Toxicity: dermal

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No effects
Body weight:
Normal weight gain
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.