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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 222-720-6 | CAS number: 3586-55-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study already available
Test material
- Reference substance name:
- (ethylenedioxy)dimethanol
- EC Number:
- 222-720-6
- EC Name:
- (ethylenedioxy)dimethanol
- Cas Number:
- 3586-55-8
- Molecular formula:
- No exact molecular formula can be given for a complex reaction mixture (UVCB substance).
- IUPAC Name:
- [2-(hydroxymethoxy)ethoxy]methanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality (Himalayan spotted).
- Sex:
- female
- Details on test animals and environmental conditions:
- Source RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
Age/weight at study initiation
Age at pretest start/beginning of acclimatization period: 4 - 6 weeks.
Body weight of pretest groups at start of pretest: 335 to 379 g.
Body weight of control and test group at beginning of acclimatization period: 356 to 410 g.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund’s Adjuvant – Complete
- Concentration / amount:
- Intradermal induction: 5% in purified water and FCA:physiological saline. Epidermal induction: 50% in purified water.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% in purified water.
- Day(s)/duration:
- Day 22 (2 weeks after epidermal induction).
- No. of animals per dose:
- Intradermal Pretest: 1 female.
Epidermal Pretest: 2 females.
Control Group in Main Study: 5 females.
Test Group in Main Study: 10 females. - Details on study design:
- Rechallenge: Not performed.
Scoring schedule: 24 and 48 h after challenge - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- Total no. in group:
- 5
- Remarks on result:
- other: result not stated
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- other: result not stated
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Ten female Himalayan spotted guinea pigs each received intradermal applications of 5% MERGAL V615 in both purified water and in a 1:1 (v/v) mixture of FCA: physiological saline, followed a week later by an epidermal application of 50% MERGAL V615 in purified water (occlusive) during the induction period. Two weeks after the epidermal induction, the animals received a topical application of the test article (25% in purified water), which was the previously determined maximum non-irritating concentration of the test article. Twenty-one hours after removal of the dressing, treated sites were depilated as described previously. Five guinea pigs served as controls that received the intradermal and epidermal inductions without the test agent. Two weeks after induction, the control animals received challenge applications of purified water and 25% MERGAL V615 in purified water. All animals were observed for erythema and oedema at 24 and 48 hours after removal of the occlusive dressings.
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.
