Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 806-879-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Dec 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CARON-St Germain-Laxis, 77950 Maincy, France
- Sex: male
- Weight at study initiation: about 2.5 - 3 kg
- Housing: in individual polysterene cages of standardized dimensions with perforated floor
- Diet: Pietrement C15, ad libitum
- Water: tap water provided in sterilized makrolon bottles equipped with stainless steel pipettes, ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 50 - 80
- Air changes (per hr): 3000 m³
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 4, 24, 48, 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
Draize scoring system according to EEC guideline 67/548
TOOL USED TO ASSESS SCORE: 2% aequous solution of sodium fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The observed lesions in all 3 animals were benign, exclusively conjunctival and of low intensity. They are fully reversible by day 2.
Any other information on results incl. tables
Table 1: Individual scores of the animals.
Reading time point |
Animal No. |
Cornea |
Iris |
Conjunctiva |
|||
Area of opacity |
Opacity |
Redness |
Chemosis |
Lacrimation |
|||
4 h |
1100 |
0 |
0 |
0 |
2 |
0 |
0 |
1101 |
0 |
0 |
0 |
2 |
0 |
0 |
|
1102 |
0 |
0 |
0 |
2 |
0 |
0 |
|
24 h |
1100 |
0 |
0 |
0 |
1 |
0 |
0 |
1101 |
0 |
0 |
0 |
1 |
0 |
0 |
|
1102 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
1100 |
0 |
0 |
0 |
0 |
0 |
0 |
1101 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1102 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
1100 |
0 |
0 |
0 |
0 |
0 |
0 |
1101 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1102 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 days |
1100 |
0 |
0 |
0 |
0 |
0 |
0 |
1101 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1102 |
0 |
0 |
0 |
0 |
0 |
0 |
|
mean 24-48-72 h |
1100 |
0.0 |
0.0 |
0.0 |
0.3 |
0 |
0.0 |
1101 |
0.0 |
0.0 |
0.0 |
0.3 |
0 |
0.0 |
|
1102 |
0.0 |
0.0 |
0.0 |
0.3 |
0 |
0.0 |
|
mean |
0.0 |
0.0 |
0.0 |
0.3 |
0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
