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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: scoring system
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KMC-113, Alkylnaphthalin
- Physical state: colorless liquid
- Analytical purity: no data
- Isomers composition: no data
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H. Fortkamp, Lengerich, Germany
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.36 - 2.46 kg
- Housing: singly in steel cages with perforated plate floors above litter-filled dung troughs
- Diet (e.g. ad libitum): Ssniff K complete rabbit diet (Ssniff Versuchstier-Diäten GmbH, Soest, Germany), ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye of the animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL; test substance was instilled into the conjunctival sac of the left eye. Then, the eye was held closed by gently pressing both eye lids together for about 1 - 2 seconds.
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): following application no further treatment of the eye

SCORING SYSTEM: according to Draize; grading scale (additional parameters included: discharge of conjunctiva and area of cornea involved) and scoring different from OECD TG 405

TOOL USED TO ASSESS SCORE: the eyes of test animals were examined after application of 2% fluorescein solution

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 1 d
Remarks on result:
other: After one hour, slight redness (score 1) was observed in all three test animals.
Irritant / corrosive response data:
Only a slight irritating effect (conjunctivae redness score 1) was observed in all test animals at 1 hour after test substance administration. At 24 hours, this finding had subsided and was not seen any more. Scores for all eye irritation parameters were 0 starting from 24 hours onwards. Observation ended at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information