Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
other: read across from similar substance
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): NA
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Details on study design:
OBSERVATION TIME POINTS
1 hour, 24 hours, 8 days

SCORING SYSTEM:
- Parameters evaluated: reddening, edema, scabbing, necrosis, turbidity, scarification
- Descriptors: questionable, minimal, moderate, marked, without effect

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
test and control item
Basis:
mean
Time point:
other: 1 h/24 h/ 8 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
test and control item
Basis:
mean
Time point:
other: 1/24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
test and control item
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
test and control item
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
test and control item
Basis:
mean
Time point:
other: 14 h/8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
not irritating
Conclusions:
not irritating to eyes