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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
Study period:
1984-11-13 to 1984-11-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Produced by Hüls AG, purity > 98 %, main impurities naphthalene and decahydronaphthtalene

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.2-2.7 kg
- Number of animals: 3 males, 3 females

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- undiluted
- Amount applied: 0.1 ml
- Controls: untreated (left) eye
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
 Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6 days after treatment
Number of animals or in vitro replicates:
6
Details on study design:

EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6 days after treatment
- Scoring system: Draize (1959); Appendix VI of 79/831/EEC
- Tool used to assess score: Na fluorescein / ophthalmic lamp / visual  inspections

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
5.17
Max. score:
110
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.33
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Reversibility:
fully reversible within: 48 h

Applicant's summary and conclusion

Conclusions:
According to the outcome of the study in rabbits slight to mild and reversible conjunctival effects were noted but in this study, tetrahydronaphthalene was not considered to be an eye irritant.
Executive summary:

In a primary eye irritation study 0.1 mL of undiluted tetrahydronaphthalene was instilled into the conjunctival sac of one eye of three male and three female young adult White Russian rabbits. Eyes were not rinsed. Animals were observed for 6 days. 

Cornea and iris were not affected. Slight to mild and reversible conjunctival effects were observed. In this study, tetrahydronaphthalene was not an eye irritant.