Registration Dossier
Registration Dossier
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: 203-713-7 | CAS number: 109-86-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A study which is sufficiently well reported to be able to judge it reliable for hazard assessment purposes. Original study only partly available (methodology and summary of results - no detailed results eg individual animal data.) Not to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Proposal of limit concentrations for skin irritation within the context of a new EEC directive on the classification and labelling of preparations
- Author:
- Jacobs G, Martens M, Mosselmans G
- Year:
- 1 987
- Bibliographic source:
- Reg Tox Pharmacol, 7, 370-8
- Reference Type:
- publication
- Title:
- (1989), Evaluation of a non-invasive human and an in vitro cytotoxicity method as alternatives to the skin irritation test on rabbits,
- Author:
- Jacobs G, Castellazzi A, Dierickx PJ
- Year:
- 1 989
- Bibliographic source:
- Contact Dermatitis, 21(4), 239-44
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , full animal data not reported in study reports
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-methoxyethanol
- EC Number:
- 203-713-7
- EC Name:
- 2-methoxyethanol
- Cas Number:
- 109-86-4
- Molecular formula:
- C3H8O2
- IUPAC Name:
- 2-methoxyethanol
- Details on test material:
- Purity: analytical grade.
Supplier: reference no: 10, 989-4 from Janssen Chimica, Beerse, Belgium
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ‘Proefstations voor veeteelt” (Merelbeke, Belgium.)
- Age at study initiation: 9-24 weeks
- Weight at study initiation: 2.0 - 5.2kg
- Housing: Animals were housed (size 40x36x47.5cm) individually in wire mesh bottom cages.
- Diet (e.g. ad libitum): Conventional rabbit chow (ref 112-animalabo, Brussels) available ad libitum.
- Water (e.g. ad libitum): tap water available ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Experiment was part of a large study examining a large number of other substances for skin irritancy.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 28 days
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: 6cm2
- % coverage:
- Type of wrap if used: Mefix and then Blenderm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water and detergent
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: maximum degree of eschar formation
- Basis:
- other: maximum
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance shows no signs of skin irritation when tested using a standard method.
- Executive summary:
In a well reported study in rabbits carried out to an EU protocol for irritancy testing, 2 -methoxyethanol showed no sign of irritation to the skin in any of the 5 animals tested.
Synopsis:
Not irritating
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.
