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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (missing data on purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Naphthalimid Tr. (dry)
- Physical state: solid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3 - 4 kg
- Housing: individually
- Diet: Ssniff K 24, Versuchstierdiaeten GmbH, Soest, D, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (maximum 0.1 g)
Duration of treatment / exposure:
Treatment was once.
Observation period (in vivo):
day 7
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Rinsing was mentioned as part of the general procedure, but was not explicitly reported for this test substance.

SCORING SYSTEM: OECD Draize score

TOOL USED TO ASSESS SCORE: fluorescein / UV light at the 24 h reading and in case of observations at later readings

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information