Registration Dossier
Registration Dossier
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EC number: 428-320-1 | CAS number: 71308-16-2
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: Guideline study according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males 22 months, female 22 months
- Weight at study initiation: males 2.49, 2.76 kg, female 2.89 kg
- Housing: individually
- Diet: approx. 120 g/animal x day standard diet sniff K
- Water: ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0-19.5°C
- Humidity (%): 38-72%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28.11.1995 To: 08.12.1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 25.8-28.9 mg - Duration of treatment / exposure:
- Single exposure, no washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3; 2 males and 1 female
- Details on study design:
- TOOL USED TO ASSESS SCORE: the treated eye was examined using a Cliptrix pencil light (supplied by Varta, Hannover)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Other effects:
- In the cornea and iris no alterations could be detected during the observation period.
The conjunctiva of one animal reacted with hyperemia (grade 1) only one hour after application. In the two other animals the conjunctiva remained
unchanged. No systemic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The substance is classified as non-irritant in this test system
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