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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to EU B.5 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material: N4,N4'-Diphenyl-N4,N4'-di-m-tolyl-biphenyl-4,4'-diamine
Physical state: white powder
Xerox chemical 17641-2-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
100 MG
Observation period (in vivo):
24h, 48h, 72h, 96h, 7 days,10 days, 13 days
Number of animals or in vitro replicates:
20 rabbits 12 of these received a washout 30 s following instillation with 100 ml lukewarm dist. water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
unwashed
Basis:
mean
Time point:
other: 24 h
Score:
5.1
Remarks on result:
other: untreated control: 0.3 at 72h
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
washed
Basis:
mean
Time point:
other: 24h
Score:
1.6
Remarks on result:
other: untreated control:0.0 for the duration of the study
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 10 days
Other effects:
100 mg/unwashed eye: slight irritation

100 mg/washed eye: minimal irritation

Applicant's summary and conclusion

Interpretation of results:
other: not classified