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EC number: 254-052-6 | CAS number: 38640-62-9
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- 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:
- 1 982
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- 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.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effetcs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- 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
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