Registration Dossier
Registration Dossier
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EC number: 202-445-8 | CAS number: 95-73-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-04-22 to 1986-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzene, 2,4-dichloro-1-methyl-
- IUPAC Name:
- Benzene, 2,4-dichloro-1-methyl-
- Reference substance name:
- 2,4-dichlorotoluene
- EC Number:
- 202-445-8
- EC Name:
- 2,4-dichlorotoluene
- Cas Number:
- 95-73-8
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 2,4-dichloro-1-methylbenzene
- Details on test material:
- Purity: > 99 %
Impurities: 4-chlorotoluene, 3,4-dichlorotoluene and further isomeres of 2,4-dichlorotoluene
Constituent 1
Constituent 2
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: 2.6 - 3.0 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 2,4-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 after application
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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 2,4-dichlorotoluene is classified as not irritating.
2,4-dichlorotoluene is not subject to specific labeling under current EU regulations. - Executive summary:
In an eye irritation study 0.1 mL of undiluted 2,4-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 7 days.
Observation of the eyes occurred 1 h, 24 h, 48 h, 72 h and 7 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, iris and chemosis and in an irritation score of 0.9 for conjunctivae.
Due to the result of this study 2,4-dichlorotoluene is classified as not irritating.
2,4-dichlorotoluene is not subject to specific labelling under current EU regulations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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