Isopropylnaphthalene

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: scoring system

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(isopropyl)naphthalene

EC Number:

254-052-6

EC Name:

Bis(isopropyl)naphthalene

Cas Number:

38640-62-9

Molecular formula:

C16H20

IUPAC Name:

Bis(isopropyl)naphthalene

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