Registration Dossier
Registration Dossier
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EC number: 210-155-8 | CAS number: 608-25-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-methylresorcinol
- EC Number:
- 210-155-8
- EC Name:
- 2-methylresorcinol
- Cas Number:
- 608-25-3
- Molecular formula:
- C7H8O2
- IUPAC Name:
- 2-methylbenzene-1,3-diol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- other: other eye of same animal
- Amount / concentration applied:
- 0.1 ml (50.6 mg)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h, 7 d, 21d
- Number of animals or in vitro replicates:
- 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: The instillation of the undiluted test substance into the eye of one rabbit resulted in effects on the cornea, iris and conjunctiva. The cornea injury consisted of opacity (maximum grade 3) and epithelial damage (maximum 100% of the corneal area)
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 days
Any other information on results incl. tables
Guideline: OECD 405 (2002)
Species: New Zealand White rabbit
Group: 1 male
Test substance: 2 -methylresorcinol
Purity: 98.6%
Dose: 50.6mg (approx 0.1ml)
GLP: in compliance
The equivalent of 0.1 ml of the test substance was instilled into the conjunctival sac of one
eye of the test animal. The substance remained in permanent contact with the eye until
rinsing with warm tap water, 24 hours after instillation. The other eye served as control.
The instillation of the undiluted test substance into the eye of one rabbit resulted in effects
on the cornea, iris and conjunctiva.
The cornea injury consisted of opacity (maximum grade 3) and epithelial damage
(maximum 100% of the corneal area). As a result of the corneal injury, pannus
(neovascularisation of the cornea) was apparent 7, 14 and 21 days after instillation. Iridial
irritation grade 1 was observed from days 1 to 7 after instillation. The irritation of the
conjunctiva consisted of redness and chemosis. Redness persisted up to termination. In
addition, the eyelids and/or nictitating membrane showed grey-white discoloration (sign of
necrosis) between days 1 and 7 after instillation. Reduced elasticity of the eyelids was noted
between 72 hours and 21 days after exposure.
Conclusion
Based on the degree and persistence of the eye injury, it was concluded that ocular
corrosion had occurred by instillation of undiluted test substance into the rabbit eye.
Undiluted substance is severely irritant to the rabbit eye.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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