Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
0.1 ml of the test substance were applied into the conjunctival sac of the left eye of each animal. The right eye was not treated and served as control. The treated eye of animals 4-6 was cautiously rinsed with 10 ml luke warm water after 4 seconds of application.
Observation period (in vivo):
1 hour; observation was stopped after 1 hour due to severe effects in the eye.
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
3
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Application of 0.1 ml (Z)-2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol into the conjuncival sac of White New Zealand rabbits caused severe eye damage.
Executive summary:

An acute eye irritation test according to OECD Guideline 405 was carried out with (Z)-2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol in White New Zealand rabbits. The substance caused severe eye damage.