Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No GLP study. Documentation insufficient for an assessment of reliability.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No data
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): biphenyl

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg applied as finely ground sample
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
at 1, 24, 48, 72, 120 and 168 hrs
Number of animals or in vitro replicates:
6
Details on study design:
No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
11.6
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
8
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
0.6
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Immediate: discomfort was slight
10 Min.: Slight erythema, copious discharge
1 hour: Moderate erythema, very slight edema in five instances, copious discharge
24 hours: Slight erythema, copious discharge with slight whitish exudate
48 hours: Gradual improvement
72 hours: All scored zero

Any other information on results incl. tables

Immediate: discomfort was slight

10 Min.: Slight erythema, copious discharge

1 hour: Moderate erythema, very slight edema in five instances, copious discharge

24 hours: Slight erythema, copious discharge with slight whitish exudate

48 hours: Gradual improvement

72 hours: All scored zero

Applicant's summary and conclusion

Conclusions:
Slight erythema was observed with copious discharge at 1 and 24 hours (after 24 hours exposure to biphenyl). At 48 hours, gradual improvement was observed and the observed effects were fully reversible within 72 hours.