Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: US Federal Register 38, No. 187, § 1500.42
Deviations:
yes
Remarks:
limited reporting, observation period: 72 hours
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-(2-Ethylhexyl)-2-napthalinamin
- Physical state: liquid
- Analytical purity: 80%
- Impurities (identity and concentrations): 20% Shellsol
- Lot/batch No.: 79/502

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean weight: 3.59 kg
- Housing: no data
- Diet: Ssniff, no further data
- Water: no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single exposure
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data


SCORING SYSTEM: accordings to draize


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.33
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: expected to reverse within 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24748/72 hours
Score:
0

Any other information on results incl. tables

The mean scores (24/48/72 hours) for corneal opacity, iris lesions and chemosis were 0 and the mean score for redness of the conjunctivae was 1.33. The substance is not irritating to eyes according to EU and GHS-criteria.

Applicant's summary and conclusion

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