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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Unreliable testing facility: study protocol equivalent or similar to OECD Guideline 405 (no details on test animals, only 1- 24-, 72-hour and 7-day scores available, 7-day observation period; TS purity not specified; no GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 7 day observation, no scoring done at 48h
Principles of method if other than guideline:
Draize test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Lot/batch No.: 3749/72 (1972-11-16)
No additional details provided

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young albino rabbits of the New Zealand strain were used in the evaluation of the primary skin irritating properties of the test material (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): 0.1 ml
Duration of treatment / exposure:
unlimited (the test substance was not washed out)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: comparable to the OECD scoring system (irritation scores determined only after 24 hours, after 72 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
Remarks:
opacity
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scores not provided
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-72-hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scores not provided
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-72-hour
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scores not provided
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scores not provided
Irritant / corrosive response data:
No sign of eye irritation was observed 24 h, 72 h or 7 days after treatment. It can be therefore assumed that the test substance is not irritating according to EU-CLP.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information