Registration Dossier
Registration Dossier
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EC number: 272-812-5 | CAS number: 68915-39-9
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 68995-39-9
- IUPAC Name:
- 68995-39-9
- Details on test material:
- - Name of test material (as cited in study report): Anolonablauge
- Composition of test material, percentage of components:
Adipic acid (Cas No. 124-04-9) 4.8%
Hexanoic acid, 6-hydroxy (Cas No. 1191-25-9) 4.1%
Glutaric acid (Cas No. 110-94-1) 0.7%
Succinic acid (Cas No. 110-15-6) 0.5%
Valeric acid (Cas No. 109-52-4) 4.8%
Hexaconic acid (Cas No. 142-62-1) 1.2%
Butyric acid (Cas No. 107-92-6) 1.0%
Propionic acid (Cas No. 79-09-4) 0.3%
Acetic acid (Cas No. 64-19-7) 0.5%
Formic acid (Cas No. 64-18-6) 1.5%
Sodium 9.0%
Sodium carbonate (Cas No. 497-19-8) 0.5%
Sodium hydrogencarbonate (Cas No. 144-55-8) 1.0%
Water (Cas No. 7732-18-5) 55.0 %
Cobalt 4 ppm
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach
- Mean weight at study initiation: male 3.11 Kg, female 3.07 Kg
- Housing: single
- Diet: Kliba 341 (about 130 g/animal/day)
- Water: 250 ml tap water/animal/day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- kept unwashed
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
