Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 241-624-5 | CAS number: 17639-93-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was based on EEC methodology and performed at a reputable testing facility, however no information on GLP was provided in the test report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Report states study was in accordance with EEC methodology, however no specific method was cited.
- GLP compliance:
- not specified
- Remarks:
- No information on GLP was provided
Test material
- Reference substance name:
- 2-chloropropionic acid methyl ester
- IUPAC Name:
- 2-chloropropionic acid methyl ester
- Details on test material:
- - Name of test material (as cited in study report): Methyl ACPA/ 2-Chloropropionic acid methyl ester
- Physical state: Liquid
- Analytical purity: 99.4%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1 screen animal and 3 test animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 72 hour observation period
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hour observation period
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hour observation period
- Score:
- 1.65
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hour observation peiod
- Score:
- 1.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
The details of the results are tabulated below.
Table 1.
Rabbit Number and Sex |
Region of Eye |
One Hour |
Day after Instillation |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||||
2966* Male |
Cornea |
Density |
0 |
0 |
0 |
0 |
|
|
|
|
Area |
0 |
0 |
0 |
0 |
|
|
|
|
||
Iris |
0 |
0 |
0 |
0 |
|
|
|
|
||
Conjunctiva |
Redness |
2 |
2 |
2 |
0 |
|
|
|
|
|
Chemosis |
1 |
1 |
1 |
0 |
|
|
|
|
||
2967 Male |
Cornea |
Density |
1 |
1 |
2 |
2 |
2 |
2 |
1 |
0 |
Area |
3 |
3 |
1 |
2 |
2 |
1 |
1 |
0 |
||
Iris |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
2 |
2 |
3 |
2 |
2 |
1 |
0 |
|
Chemosis |
1 |
3 |
3 |
3 |
3 |
1 |
0 |
0 |
||
590 Female |
Cornea |
Density |
4 |
2 |
1 |
1 |
1 |
0 |
|
|
Area |
1 |
2 |
1 |
1 |
1 |
0 |
|
|
||
Iris |
|
0 |
1 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctiva |
Redness |
2 |
2 |
2 |
1 |
1 |
0 |
|
|
|
Chemosis |
1 |
2 |
1 |
1 |
0 |
0 |
|
|
||
418 Female |
Cornea |
Density |
2 |
2 |
1 |
1 |
0 |
0 |
|
|
Area |
1 |
1 |
1 |
1 |
0 |
0 |
|
|
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctiva |
Redness |
1 |
1 |
1 |
1 |
1 |
0 |
|
|
|
Chemosis |
1 |
1 |
1 |
1 |
1 |
0 |
|
|
||
* Screen animal - eye rinsed 30 seconds after dosing.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Instillation of Methyl ACPA into the rabbit eye produced corneal lesions (up to grade 4 opacification), inflammation of the iris (grade 1) and moderate conjunctival irritation.
- Executive summary:
The eye irritation effect of methyl-2-chlorpropionic acid was evaluated in a study performed in accordance with EEC methodology. Methyl-2-chloropropionic acid (0.1ml) was dosed into one eye of each of four rabbits.
One animal was treated in advance of the others as a screen; the eye of this animal only was washed for 30 seconds after 30 seconds exposure. The treated eyes were assessed for up to 21 days after treatment.
Instillation of the test substance into the rabbit eye produced corneal lesions (up to grade 4 opacification), inflammation of the iris (grade 1) and moderate conjunctival irritation.
Although the observed effects are not sufficient to trigger a classification requirement as ‘irritating to eyes’ according to CLP criteria, the classification listed under Annex VI of Regulation (EC)1272/2008 includes classification for eye irritation.
In view of this, the registrant adopts the classification 'Eye Irritant 2' as listed in Annex VI.
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.
