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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.11.2000 - 5.01.2001
- 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 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Allergic contect dermatitis in the Guinea-Pig: identification of contact allergens
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
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:
- - Physical state: Liquid
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Biotechnology & Animal Breeding Division (RCC Ltd.), Füllinsdorf, Switzerland
- Age at study initiation: 5 weeks old
- Weight at study initiation:
- Housing: Group housing of 5 animals per labelled metal cage with mesh floors
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1000 mg/Kg)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days before the start treatment
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 artificial fluorescent light / 12 hours dark per day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 5% for a intradermal induction and a 100% concentration for the epidermal induction exposure
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 5% for a intradermal induction and a 100% concentration for the epidermal induction exposure
- No. of animals per dose:
- Intradermal injections:
10 in test group, 5 controls
Epidermal application:
Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches - Challenge controls:
- During induction, the control animals were treated as described for the experimental animals except that, instead of the test substance, vehicle alone was administrated. All animals underwent the challenge
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% induction, 100% challenge
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions were evident in the control animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% induction, 100% challenge. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were evident in the control animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% induction, 100% challenge
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions were evident in the control animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% induction, 100% challenge. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were evident in the control animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- may cause sensitisation by skin contact
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.
