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Administrative data

Description of key information

The oral and dermal LD50 values in rats were > 2000 mg/kg bw in reliable studies according to OECD guidelines 425 and 402.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Key study is reliable without restrictions

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Key study is reliable without restrictions

Additional information

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

The test substance, 1-chloro-2,3-dimethylbenzene, was evaluated for its acute toxicity 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. This result is supported by a less reliable study.

Justification for classification or non-classification

Due to LD50 values of > 2000 mg/kg bw for oral and dermal exposure, no classification for acute toxicity is required according to the criteria of Regulation (EC) No 1272/2008.