Registration Dossier
Registration Dossier
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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
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