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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: 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:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Draize method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Mixture of partially hydrogenated terphenyls
- Physical state: Light-yellow clear liquid
- Impurities (identity and concentrations): 0.15% phenyl cyclohexane and 6.79% high boilers

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.