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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 444-010-7 | CAS number: 82654-98-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.11.00 - 21.11.00
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 444-010-7
- EC Name:
- -
- Cas Number:
- 82654-98-6
- Molecular formula:
- C12H18O3
- IUPAC Name:
- 4-(butoxymethyl)-2-methoxyphenol
- Details on test material:
- - Substance type: Liquid
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: between 1.0 and 3.5 kg
- Housing: Individually housed in labelled cages with perforated floors and equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet, 100 gr. per day
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: 5 days before the treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+-3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 animals of one sex
- Details on study design:
- TEST SITE
- Area of exposure: 150 square centimeters
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours and 24 minutes
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.07
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
Any other information on results incl. tables
INDIVIDUAL SKIN IRRITATION SCORE:
| Animal # | 1 | 2 | 3 | ||||||
| Time after exposure | Erythema | Edema | Comments | Erythema | Edema | Comments | Erythema | Edema | Comments |
| 1 hour | Well defined | No edema | - | Well defined | No edema | - | Well defined | No edema | - |
| 24 hours | Well defined | Very slight | - | Well defined | Very slight | - | Well defined | Very slight | - |
| 48 hours | Very slight | Very slight | - | Very slight | Very slight | - | Very slight | Very slight | - |
| 72 hours | Very slight | No edema | r | Very slight | No edema | l | Very slight | No edema | l,r |
| 7 days | No erythema | No edema | l | No erythema | No edema | l | No erythema | No edema | l |
r: Erythema at the edges of the application-area
l: Scaliness
ANIMAL SPECIFICATIONS:
| Animal n° | Sex | Age (weeks) | Body weight (gr) |
| 1 | Male | 7 -9 | 1488 |
| 2 | Male | 7 -9 | 1529 |
| 3 | Male | 7 -9 | 1545 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The scaliness, as observed after 7 days, was considered to be reversible skin reaction that resolves within the full study period of 21 days.
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.
