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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
o-phenylenediamine
EC Number:
202-430-6
EC Name:
o-phenylenediamine
Cas Number:
95-54-5
Molecular formula:
C6H8N2
IUPAC Name:
benzene-1,2-diamine
Details on test material:
- Name of test material (as cited in study report): o-Phenylendiamin

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Weight: 2.3 - 2.8 kg
Age: 3- 5 months
Animals husbandry: in single cages
Room temperature: 20 +/- 3 °C
rel. air humidity: 50 +/- 20 %
Illumination: 12 hours daily
Food: Altromin 2123 diat ad libitum, company Altromin-GmbH, Lage/Lippe, Germany, hay approx. 15 g / day
Water: de-ionised, chlorinated water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye of each rabbit remained untreated and served as control
Amount / concentration applied:
A single dose of 100 mg substance was applied.
Duration of treatment / exposure:
The substance was placed into the conjunctival sac of the left eye, the right eye remained untreated and served as control. 24 h after treatment eyes were rinsed with physiol saline solution.
Observation period (in vivo):
examinations were done 1, 24, 48, and 72h, and 7, and 14d after application.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72h
Score:
3.3
Reversibility:
fully reversible within: 14d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48, and 72h
Score:
2.3
Reversibility:
fully reversible within: 14d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48, and 72h
Score:
3
Reversibility:
fully reversible within: 14d
Irritation parameter:
conjunctivae score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, and 72h
Score:
3
Reversibility:
fully reversible within: 14d
Irritation parameter:
iris score
Basis:
other: animal # 1, 2, and 3 each
Time point:
other: mean of 24, 48, and 72h
Score:
1
Reversibility:
fully reversible within: 7-14d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72h
Score:
2.3
Reversibility:
fully reversible within: 14d
Irritation parameter:
cornea opacity score
Basis:
other: animal # 2, and 3 each
Time point:
other: mean of 24, 48, and 72h
Score:
2
Reversibility:
fully reversible within: 7d
Irritant / corrosive response data:
clear brown discharge - effect fully reversible within 24h
white mucous discharge - effect fully reversible within 72h
conjunctivae brown discoloured - effect fully reversible within 48h
conjunctivae white discoloured - effect fully reversible within 14d
conjunctival haemorrhage - effect fully reversible within 7d

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
All effects were fully reversible within the observation period. Mean scores calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis indicate that the substance is irritating to eyes.
Executive summary:

o-phenylenediamine was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were placed into the conjunctival sac of the left eye of 3 New Zealand White Rabbits each. The right eye served as untreated control. 1, 24, 48, and 72h, and 7, and 14d after application eyes were examined. 24 h after treatment eyes were rinsed with physiol. saline. Mean scores (mean of 24, 48, and 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit.

All effects were fully reversible within the observation period. Mean scores calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis indicate that the substance is irritating to eyes.

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