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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Carbon Black, Spezialschwarz 4

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: albino rabbits, New Zealand strain, average weight 2.3-2.8 kg. 3 male, and 3 female animals.
HOUSING: stainless steel cages, 1 animal/cage, standard diet (Altromin), water ad lib., temperature 21 +/- 2 deg C, relative humidity 60 +/- 3%, 12 hours artificial light/12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
undiluted
Amount applied: 100 mg
Duration of treatment / exposure:
EXPOSURE TO THE TEST SUBSTANCE: 100 mg of the test substance was instilled into the left eye. The other eye was treated with physiological saline solution and served as control. The eyes were not rinsed.
Observation period (in vivo):
OBSERVATIONS: eyes were evaluated for erythema, edema, and effects on cornea and iris according to the Draize score at 24, 48, 72 and 96 hours after instillation.
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritant effects were found in any of the animals at any observation (scores for cornea, iris and conjunctivae: 0.0, 0.0, 0.0).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
not an eye irritant