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Toxicological information

Eye irritation

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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:
2008

Materials and methods

Test guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

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