Registration Dossier
Registration Dossier
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EC number: 262-967-7 | CAS number: 61788-32-7
Eye irritation
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: This study appears to be in non-compliance with 21 CFR Part 58 but is appropriate to assess potential eye irritation from ocular contact.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- no
Test material
- Reference substance name:
- Terphenyl, hydrogenated
- EC Number:
- 262-967-7
- EC Name:
- Terphenyl, hydrogenated
- Cas Number:
- 61788-32-7
- Molecular formula:
- C18Hn (n >18-36)
- IUPAC Name:
- Terphenyl, hydrogenated
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Isacc's Farm, Litchfield, Illinois
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 2 to 3 kg
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6 animals (3 Males and 3 Females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed after test material administration
Reading times: 24, 48 and 72 hours
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- other: Draize score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48h
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mean Draize socre = 0.3 on a scale of 110
- Executive summary:
When 0.1 mL of undiluted Terphenyl, hydrogenated was instilled into the conjunctival sac of the rabbit eye, the average of the Draize irritation score for 24, 48 and 72 hours was 0.3 on a scale of 110 in six rabbits. Minor corneal involvement was observed in one eye during the study. All treated eyes had regained a normal appearance by the second day of observation.
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