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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 214-730-4 | CAS number: 1191-16-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study (fluorescein examination performed)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Primary Eye Irritation in Rabbits with Prenyl Acetate
- Author:
- Rhodia Inc.
- Year:
- 1 978
- Bibliographic source:
- cited in TSCATS; OTS0571762
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methyl-2-butenyl acetate
- EC Number:
- 214-730-4
- EC Name:
- 3-methyl-2-butenyl acetate
- Cas Number:
- 1191-16-8
- Molecular formula:
- C7H12O2
- IUPAC Name:
- 3-methylbut-2-en-1-yl acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test substance (as cited in study report): Prenyl Acetate
- Analytical purity: > 99%
- Identifying numbers: SD4 C/6 12 ref. JRT 291-175
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, New Jersey
- Weight at study initiation: 2 - 3 kg
- Housing: 3/cage in large wire bottom cages, 71 x 86 x 71 cm (acclimation period); individually in wire bottom cages, 46 x 51 x 33 cm (study period)
- Diet: Wayne Rabbit Ration manufactured by A. Mills (2% crude fat, 17% crude protein, 15% crude fiber and 0.025% of sulfaquinoxaline); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): ca. 50
- Photoperiod (hrs dark / hrs light): 10 / 14
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 20-30 seconds, 7 days
- Observation period (in vivo):
- 7 days (readings at 24, 48 and 72 hours and 4 and 7 days post instillation)
- Number of animals or in vitro replicates:
- 9 (males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 6 animals: without washing; 3 animals: washing (treated eye flashed for 1 minute with lukewarm water)
- Time after start of exposure: washing starting no sooner than 20-30 secods after instillation
SCORING SYSTEM: according to the Draize Scoring System; calculated overall irritation score (Federal Register, Vol. 38, No. 187, September 27, 1973, p. 27019)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 3, 5 and 6
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: animal#3: discharge after 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1, 2 and 4
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Table 1: Eye irritation results (unwashed)
Reading |
Animal# |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
24 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
1 |
1 |
0 |
0 |
0 |
1 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
1 |
1 |
0 |
0 |
0 |
0 |
|
6 |
1 |
1 |
0 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Assessment of washed eyes resulted in overall scores of 0.
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.
