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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: unsuitable test system

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Chemicals were placed into conjunctival sac of the left eye. The eyes were examined and the grade of ocular reaction recorded at differents times after treatment. Ocular reactions were classified according to Draize score, and EPA toxicity categories were used for the classification of chemicals
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Diphenylamine
EC Number:
204-539-4
EC Name:
Diphenylamine
Cas Number:
122-39-4
Molecular formula:
C12H11N
IUPAC Name:
diphenylamine

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Takeo breeder (Shizuoka, Japan)
- Weight at study initiation: 2.0-2.2 kg
- Housing: metal cages 39x40x44 cm
- Diet (e.g. ad libitum): RC4 diet (Oriental yeast Co, Tokyo, Japan)
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 55
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
not specified
Controls:
other: right eye served as a blank
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):100 mg
- Concentration (if solution):0.1 ml
Duration of treatment / exposure:
21 days
Observation period (in vivo):
1, 4, 24, 48, 72 and 96 hours, 7, 14 and 21 days
Number of animals or in vitro replicates:
3 animals per chemical

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other:
Time point:
other: 21 days
Score:
> 16.9 - < 96.8
Max. score:
96.8
Reversibility:
not fully reversible within:
Remarks:
21 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Reversibility:
not specified
Remarks on result:
other: Not specified
Remarks:
Not specified
Irritant / corrosive response data:
scores 0 up to 7.0: class I (mild) of chemicals inducing no or mild damage recovering within 24 hours (23 chemicals)
scores 1.0 up to 42.8: class II (moderate to severe) of chemicals inducing severe irritation clearing within 21 days (64 chemicals)
scores 16.9 up to 96.8 : class III (corrosive) of chemicals inducing corrosive effect not recovering within 21 days (44 chemicals including diphenylamine)

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: modified EPA toxicity categories (1991)
Conclusions:
Diphenylamine is corrosive to the eye of rabbits