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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 3 Dec 2003 to 30 Dec 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
2001
GLP compliance:
yes
Test type:
up-and-down procedure
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:
rat
Strain:
other: Outbred Albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Indianapolis, IN
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: at least 49 days
- Weight at study initiation: 201.5-247.5 g
- Fasting period before study: yes
- Housing: individually
- Diet: TEK 7012 Rodent Diet, Harlan Teklad, Madison, WI, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2.8
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1 ml/100 g bw
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 and weighing: observations: twice daily on day of dosing, daily thereafter; weighing on day 0, 7, 14 and at death
- Necropsy of survivors performed: yes
Statistics:
Statistical computer program (AOT425StatPgm) developed by the United States Environmental Protection Agency

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Two out of five animals were found dead in the course of the study (Animal # 1 on Day 12 and Animal # 3 on Day 4). Three out of five animals survived the duration of the study
Clinical signs:
In four out of five animals, no clinical manifestations of toxicity were observed. In Animal # 3, piloerection was observed within 4 hours of test substance administration
Body weight:
Three out of five animals that survived the duration of the study gained weight.
Gross pathology:
No unusual findings were found during necropsy in all the dosed animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
toxicity presumably meets criteria for GHS category 5. A defnite conclusion is not possible based on the limit test. Cat 5 is not foreseen in EU CLP Regulation
Conclusions:
Under the conditions of this study, the oral LD50 in rats was > 2000 mg/kg bw
Executive summary:

The test substance, 1-Chloro-2,3-dimethylbenzene, was evaluated for its acute toxcity following oral administration of 2000 mg/kg bw (limit dose) to five female rats. Two deaths were observed in this study. One animal showed clinical signs of toxicity (piloerection). Using OECD guideline 425 as limit test, the test substance was defined to have an estimated LD50 of greater than 2000 mg/kg body weight.