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Toxicological information

Skin irritation / corrosion

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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:
1987
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:
1989
Bibliographic source:
Contact Dermatitis, 21(4), 239-44
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: analytical grade.
Supplier: reference no: 10, 989-4 from Janssen Chimica, Beerse, Belgium

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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