Registration Dossier
Registration Dossier
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EC number: 214-730-4 | CAS number: 1191-16-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 with acceptable restrictions
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Primary Dermal Irritation with Prenyl Acetate in Rabbits
- Author:
- Rhodia Inc.
- Year:
- 1 978
- Bibliographic source:
- cited in TSCATS; OTS0571762
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- (April, 1978)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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 material (as cited in study report): Prenyl Acetate
- Analytical purity: > 99%
- Identifying numbers: SD4 C/6 - 12 ref. FRT 291-175
- Physical state: liquid (clear)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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 wire bottom cages (study period)
- Diet: Wayne Rabbit Ration manufactured by A. Mills (2% crude fat, 17% crude portein, 15% crude fiber and 0.025% of sulfaquinoxaline); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 1 - 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): ca. 50
- Photoperiod (hrs dark / hrs light): 10 / 14
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated site
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h (readings at 24 and 72 h after application)
- Number of animals:
- 6 (males)
- Details on study design:
- TEST SITE
- Area of exposure: 4 2.5 x 2.5 cm application sites (2 left intact, 2 abraded)
- Type of wrap if used: gauze pad, with adhesive tape and impervious rubber cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, only wiping
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (out of 6 animals)
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (out of 6 animals)
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Erythema/Edema scores were 0 for intact and abraded skin.
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.
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