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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-425-1 | CAS number: 106-70-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 May - 07 May 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl hexanoate
- EC Number:
- 203-425-1
- EC Name:
- Methyl hexanoate
- Cas Number:
- 106-70-7
- Molecular formula:
- C7H14O2
- IUPAC Name:
- methyl hexanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl hexonate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, colourless
- Purity: > 98%
- Lot/batch No.: 1291191
- Expiration date of the lot/batch: 24.06.1994
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Weight at study initiation: approx. 2620 g
- Housing: individually
- Diet: Ssniff rabbit diet K4, ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes: at least 8/h
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:
- 24 h
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h
SCORING SYSTEM
Draize scoring system was used
TOOL USED TO ASSESS SCORE:
Slit lamp microscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: none of the animals showed corneal reaction
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: none of the animals showed iris reaction
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: redness graded 1 was seen at reading points 1, 24 and 48 hour
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: man over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: redness graded 1 was seen at reading time points 1 and 24 hour
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: none of the 3 animals showed chemosis
- Irritant / corrosive response data:
- One animal showed slight conjunctival redness of grade 1 at reading time points 1, 24 and 48 hour. A further animal showed the same finding at 1 and 24 hour; in this animal, redness at 1 hour was further accompanied by lacrimation graded 2. The third animal showed no signs of irritation at all.
Any other information on results incl. tables
Table 1: Results of eye irritation study for all reading time points
Animal |
Hours after application |
|||||||||||||||||||
1 |
24 |
48 |
72 |
|||||||||||||||||
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
|
1323 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1261 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1318 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A = Corneal Reaction
B = Irritational Reaction
C = Erythema
D = Chemosis
E = Exsudation
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.
