Registration Dossier
Registration Dossier
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EC number: 429-630-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Eldew PS-203
- Physical state: pale yellow, oily liquid
- Analytical purity: 100%
- Purity test date: not reported
- Lot/batch No.: 808010
- Expiration date of the lot/batch: 31.03.2000
- Storage condition of test material: test material was stored at room temperature (ca. 20°C), away from direct sunlight
Constituent 1
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 15 weeks
- Weight at study initiation: 2642 - 2897 g
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Eyes were not rinsed after treatment.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1 m / 2 f
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 13
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study with NZW rabbits performed according to EU Method B.5 gave no indication for eye irritation or corrosion.
- Executive summary:
A study with NZW rabbits performed according to EU Method B.5 gave no indication for eye irritation or corrosion.
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