Registration Dossier
Registration Dossier
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EC number: 201-920-7 | CAS number: 89-58-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1986-03-17 to 1986-04-1
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well performed study according to GLP and previous OECD TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-nitro-m-xylene
- EC Number:
- 201-947-4
- EC Name:
- 4-nitro-m-xylene
- Cas Number:
- 89-87-2
- IUPAC Name:
- 2,4-dimethyl-1-nitrobenzene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as contorl
- Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 1h, 24h, 48h and 72h after administration
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Other effects:
- 1hr after application clear eye discharge was observed in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study according to OECD TG 405 nitro-m-xylene was not irritating to the eye.
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