Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: AMIDE#71

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 45 mg
Duration of treatment / exposure:
Single application for 72 hour exposure.
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize scale for scoring ocular irritation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: maximum score for all animals
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 day
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No chemosis observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No chemosis observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No chemosis observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects observed
Irritant / corrosive response data:
No chemosis, corneal or iridial effects were noted during the study.
Minimal conjunctival irritation (redness, score of 1) was observed in animals after 1 hour. These effects were fully reversible within 1 day.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an eye irritant and should not be classified as an eye irritant.
Executive summary:

Eye irritation

The test substance was assessed for eye irritation according to EU Method B5. 

No chemosis, corneal or iridial effects were noted during the study. Minimal conjunctival irritation (redness, score of 1) was observed in animals after 1 hour. These effects were fully reversible within 1 day.

The substance is not an eye irritant.