Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC-Directive 92/69 B.5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
35 MG
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritant / corrosive response data:
Iridic irritation grade 1 was observed in two animals, 1 hour after instillation. The irritation of the conjunctivae consisted
of redness, chemosis and discharge and had resolved within 48 hours in one animal and within 72 hours after instillation in the other two animals.

P 93-201 was considered mildly irritating (M2) to the rabbit eye (Kay and
Calandra interpretation of the calculated maximum Draize score: 11.3).

Reversibility of any observed effect: Changes fully reversible within 3 days.
Other effects:
Remnants of the test substance were present in the eyes and
on the outside of the eyelids of all animals on day 1.

Any other information on results incl. tables

P 93-201 was considered mildly irritating (M2) to the rabbit eye (Kay and

Calandra interpretation of the calculated maximum Draize score: 11.3).

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU