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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 224-644-9 | CAS number: 4435-53-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methoxybutyl acetate
- EC Number:
- 224-644-9
- EC Name:
- 3-methoxybutyl acetate
- Cas Number:
- 4435-53-4
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 3-methoxybutyl acetate
- Reference substance name:
- butoxyl rein 98/100%
- IUPAC Name:
- butoxyl rein 98/100%
- Details on test material:
- - Name of test material (as cited in study report): Butoxyl rein 98/100%
- Physical state: Colourless clear fluid
- Analytical purity: 99.7%
- Purity test date: 8 November 1991
- Lot/batch No.: production date 21 August 1991
- Stability under test conditions: 5 years
- Storage condition of test material: darkness at room temperature in fume cupboard
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.2 kg
- Housing: individually
- Diet: Altromin 2123 ad libitum and approximately 15g hay per day
- Water: ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3°C
- Humidity: 55±20%
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 22 October 1991 To: 25 October 1991
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster, which was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no erythema at any time point
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no erythema at any time point
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no erythema at any time point
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no oedema at any time point
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no oedema at any time point
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no oedema at any time point
- Other effects:
- none
Any other information on results incl. tables
No signs of irritation were observed during the whole observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Butoxyl rein 98/100% is non irritant to skin.
- Executive summary:
The skin irritancy potential of butoxyl rein 98/100 was assessed in 3 rabbits according to OECD guideline 404. Rabbits were exposed to 0.5mL of the test substance under a semi-occlusive dressing for 4 hours, after which the patches were removed and the skin decontaminated. The skin reaction was assessed according to the numerical scoring system at approximately 1, 24, 48 and 72 hours after application.
There were no signs of irritation in any rabbit and the mean scores for erythema and oedema were 0.00.
Butoxyl was considered to be not irritating to rabbit skin.
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.
