Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-03-17 to 1989-04-05
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Content: 99,4 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test animals:
- Strain: Wistar rats.
- Source: Winkelmann, Borchen
- Sex: males and females
- Age: 2 - 3 month at the beginning of the test.
- Weight: Average weight at the beginning of the test: 180 - 190 g

Conditions:
- Temperature: 22 +/- 2°C
- Photoperiod: 12 h light / dark cycle
- Humidity: about 50 %
- Diet: Altromin R 1324 and tap water ad libitum.
- Housing: 5 animals per cage
- Acclimation period: at least 5 days
- Air changes (per hr): about 10 times per hour

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass tubes
- Method of holding animals in test chamber: exposure tubes were locked on one end in a way that the tail was outside of the tube
- Method of conditioning air: generation of compressed air and automatically conditioning

TEST ATMOSPHERE
- Assay of 2,4-dichlorotoluene in atmosphere: gas chromatography with FI-detector


Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography with FI-detector
Duration of exposure:
4 h
Concentrations:
0 mg/m³, 1270 mg/m³, 2669 mg/m³
No. of animals per sex per dose:
5 animals per sex per dose in the treatment groups and 10 animals per sex in the control group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: not clearly stated
- Frequency of weighing: before exposure, day 3, 7 and 14 post exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations with special regard to the mucous membranes of the eyes and respiratory tract, general condition, respiration, cardiovascular system, behaviour, central-nervous disturbances, reflex-activity

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 669 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no animals died during exposure or post exposure period
Clinical signs:
No clinical symptoms were recorded in animals of the control and tested group.
Body weight:
not affected
Gross pathology:
no pathological findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 value for 2,4-dichlorotoluene was determined to be > 2669 mg/m³.
Executive summary:

Acute inhalation toxicity of 2,4-dichlorotoluene has been investigated with male and female Wistar rats which were exposed for 4 hours towards 0, 1270 and 2669 mg/m³ (analytically concentrations).

Exposure to all concentrations of 2,4-dichlorotoluene was tolerated by all animals without any symptoms of intoxication.

No macroscopically visible changes occurred in the lungs or in any other tissue and organ.

No sex specific differences were observed.