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: Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
7d observation period only
Qualifier:
equivalent or similar to
Guideline:
other: 16 CFR 1500.42
Deviations:
yes
Remarks:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RD-5893; 5-Dodecylsalicylaldoxime
- Physical state: dark yellow semi-solid viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
no washout (6 rabbits) and wash-out after 4 seconds (3 rabbits)
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no wash-out
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: no wash-out
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.44
Max. score:
3
Reversibility:
not fully reversible within: 7 d (4x score 1; 1x score 2)
Remarks on result:
other: no wash-out
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 7 d (3x score 1; 1x score 2)
Remarks on result:
other: no wash-out
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 3d
Remarks on result:
other: wash-out after 4 seconds
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
1
Reversibility:
not fully reversible within: 7d (1x score 1)
Remarks on result:
other: wash-out after 4 seconds
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7d (3x score 1)
Remarks on result:
other: wash-out after 4 seconds
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.89
Max. score:
3
Reversibility:
not fully reversible within: 7d (3x score 1)
Remarks on result:
other: wash-out after 4 seconds

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is labelled as Category 2 with regard to eye irritation (irritating to the eyes).
Executive summary:

The registered substance was tested in an acute eye irritation study in white rabbits according to the 16 CFR 1500.42 protocol. 0.1 ml of the test substance was instilled to the eyes of 9 animals, 6 of which received a wash-out rinse within 4 seconds after application. 3 animals did not receive the wash-out rinse. The study was performed under GLP conditions. After 7 days post-treatment, the conjunctivitis was not reversible in the rinse group but it can be expected that the conjunctivitis would have been reversibe within 21 days as required by the OECD guideline. In the non-rinse group the effects on the iris and cornea were reversible after 7 days of observation whereas the effects on the conjunctiva were not reversible although slight (grade 1). It can be expected that the effect would have been reversible if the observation period had been prolonged. Although the FDA study protocol is not fully in line with European study protocols, the results can be interpreted on the basis of Regulation (EC) 1272/2008. The test substance is considered to be irritating to the eyes (GHS Category 2).