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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-04-08 to 1986-04-22
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Purity: > 99 %
Colour: colourless
Impurities: 2,4-dichlorotoluene and further isomeres of di-chlorinated toluenes.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Number of animals: 3
- Average weight at study initiation: 2.4 - 3.3 kg
- Age: 3 - 5 month

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Photoperiod: 12 h dark, 12 h light
- Diet: "Altromin 2123" ad libitum an 15 g hay per day
- Water: water (ad libitum)
- Housing: one animal per cage

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of test animal
Amount / concentration applied:
0.1 mL of 3,4-Dichlorotoluene in on eye of each animal
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1 h, 24 h, 48 h,72 h and 7 days and 14 days after application
Number of animals or in vitro replicates:
3
Details on study design:
Eyes were inspected for integrity before the testing.
The test substance was placed in the conjunctival sac of one eye of each animal.
The other eye, which remains untreated, serves as a control.
Eyes were rinsed with physiological saline 24 hours after instillation.
Eyes were examined 1, 24, 48, 72, 168 and 336 hours after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average of observation period
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average of observation period
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average of observation period
Score:
0.8
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average of observation period
Score:
0.1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to the result 3,4-dichlorotoluene is classified as not irritating.
3,4-dichlorotoluene is not subject to specific labeling under current EU regulations.
Executive summary:

In an eye irritation study 0.1 mL of undiluted 3,4-dichlorotoluene was instilled into the conjunctival sac of one eye of New Zealand White Rabbits (3 animals) for 24 hours. After 24 h eyes were rinsed with physiological saline. The untreated eye served as control.

Animals were observed for 14 days.

Observation of the eyes occurred 1 h, 24 h, 48 h, 72 h and 7 days and 14 days after application of the test substance.

Eye irritation was scored according to OECD GL 405.

The findings resulted in irritation scores of 0 for cornea and iris and in an irritation score of 0.8 for conjunctivae and 0.1 for chemosis.

Due to the result of this study 3,4-dichlorotoluene is classified as not irritating.

3,4-dichlorotoluene is not subject to specific labeling under current EU regulations.