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:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: p-chlorophenyl isocyanate, no data on purity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
dosage: 0.1 g
Duration of treatment / exposure:
no information if eyes were rinsed after application of test substance
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
3.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: degree of opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: degree of opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: degree of opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: degree of opacity

Any other information on results incl. tables

RS-Freetext:
Redness (up to score 3 of max.3) and chemosis (up to score 4
of max.4) appeared on day 1; discharge (score 2 of 
max.3), congestion of the iris (score 1 of max.2) and
opacity of the cornea (up to score 4 total area of max. 4)
on day 2. These effects were observed in all animals and did
not regress before day 5.
Details of the iris were not visible in 2 animals from day
14 and in 3 animals from day 15.
At the end of the observation period (day 21) chemosis (in
5/6 score 1 of max.4), redness in 2/6 sore 1 and 1/6 score 3
of max. 3) and congestion of the iris persisted for the
majority of the animals (in 3/6 score 1 of max 4 and in 2/6
iris not visible) and opacity in all animals (in 5/6 score 1
one quarter of the area and in 1/6 score 4 total area of
max. 4)

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

method: the study was conducted according the recommendation of the OECD guideline no 405.

result: Redness and chemosis appeared on day 1, discharge, congestion of the iris and opacity of the cornea on day 2. these reactions were very important and observed in all animals. they did not regress before day 5. details of the iris were not visible in 2 animals from day 14 and in 3 animals from day 15. at the end of the observation period (day 21), chemosis, redness and congestion of the iris persisted for the majority of animals and opacity of cornea in all animals. the compound was considered as irritant.