Registration Dossier
Registration Dossier
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EC number: 210-155-8 | CAS number: 608-25-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened
- Amount / concentration applied:
- 0.5 gram
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: application of the undiluted test substance resulted in very slight erythema in the treated skin-area of one out of the three treated rabbits one hour after instillation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Guideline: OECD 404
Species: New Zealand White rabbits
Group: 3 males
Test substance: 2 -methylresorcinol
Purity: 98.6%
Dose: 0.5g
GLP: in compliance
An aliquot of 0.5 g of the moistened test substance was exposed to the intact shaved back
skin of each animal for 4 hours under semi-occlusive conditions. Animals were examined
approximately 1 hour, 24, 48 and 72 hours after termination of the exposure.
Results
The test substance caused orange staining of the skin but the investigators said that this did
not affect observations.
Under the conditions of the study, application of the undiluted test substance resulted in
very slight erythema in the treated skin-area of one rabbit one hour after instillation.
Conclusion
The test substance applied undiluted to rabbit skin showed mild and transient skin irritation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In view of the experimental results (OECD 405) the substance must be classified for serious eye damage category 1 with H318 (causes serious eye damage)
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