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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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

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.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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

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.

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
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)