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
Study period:
1972
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:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
pre-GLP and pre-OECD guideline study according to BASF-internal standard
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of the test substance used in the study report: Neozaponschwarz RE
- Appearance: Solid
- Substance number: 65-4710

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.82 and 3.09 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
ca. 50 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: black test substance residues
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
other: black test substance residues
Irritant / corrosive response data:
Mild redness was observed in both eyes exposed to the test substance 1 hour after exposure. Also mild corneal opacity was observed in one of the eyes exposed to the test substance 1 hour after exposure.
Mild redness was also observed in the control eyes of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met