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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions (no details on test animals, 7-day observation period; purity not specified; non GLP)
Justification for type of information:
Category approach as part of CSR.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38 No. 187 § 1500.42
Deviations:
yes
Remarks:
eyes of 3 animals were rinsed 30 s after treatment, eyes of other 3 treated animals not
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
The substance was tested on 6 rabbits (3 males/3 females); only rabbits showing normal ophthalmic findings were included in the test.
- Housing: individually in V2A wire cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rabbit food; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum

No additional details provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
continuously (3 animals without rinsing) or 30 second (3 animals with rinsing)
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3 without rinsing and 3 with rinsing
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes of 3 rabbits were each rinsed with 10 mL lukewarm water
- Time after start of exposure: about 30 seconds after treatment

SCORING SYSTEM: comparable to the OECD scoring system after 24, 48, 72 and 96 hours, and after 7 days.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: a conjunctivae irritation index of 6 is calculated for one animal, without rinsing, 24 hours after treatment (0 in all others without); a maximal redness score of 3 (worst case assumption) could therefore have been observed in the affected animal.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: a conjunctivae irritation index of 6 is calculated for one animal, without rinsing, 24 hours after treatment (0 in all others without); a maximal chemosis score of 3 (worst case assumption) could therefore have been observed in the affected animal.
Irritant / corrosive response data:
The only sign of irritation was conjunctivae redness, chemosis and/or discharge observed in one animal (without rinsing) after 24 hours, but was completely reversible within 48 hours. It therefore can be assumed that the test substance is not irritating to the rabbit eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU