Registration Dossier
Registration Dossier
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EC number: 202-430-6 | CAS number: 95-54-5
Eye irritation
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:
- 1 989
- 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
- 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
Constituent 1
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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