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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12.08.1986 - 19.08.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12.05.1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-naphthol
EC Number:
205-182-7
EC Name:
2-naphthol
Cas Number:
135-19-3
Molecular formula:
C10H8O
IUPAC Name:
2-naphthol
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
100 mg per animal
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 concurrent animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 d

Any other information on results incl. tables

1 - 72 hours after application: conjunctival swelling (Draize scores 2 and 3), grade 2 conjunctivitis, corneal opacity (grade 1) and irits (grade 1). White discharge. 1 out of 3 animals was free of symptoms after 7 days. The other two animals showed slight to moderate conjunctivitis, one animal had iritis and white discharge. Both animals had corneal opacities with vascularization and conjunctivae were partly detached.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
former R41
Conclusions:
Under experimental conditions of this study, the test item 2-Naphthol induced severe damages to rabbit's eyes in a Draize test according OECD Guideline 405 method. According to CLP regulation, the test item 2-Naphthol was defined as Category 1 "Irreversible effects on the eyes" based on GHS criteria.
Executive summary:

A Draize test according OECD Guideline 405 method was performed to assess the potential irritation/corrosion property of 2-Naphthol.

Under experimental conditions of this study, the test item 2-Naphthol induced severe damages to the rabbits' eyes .