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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:
supporting study
Study period:
1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Across the three references, which are believed to refer to the same work, there is sufficient information to judge that the work adheres to basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicity of this substance

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
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, 239-44

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: analytical grade.
Supplier: reference no: 830 from Fluka AG, Buchs, Switzerland

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:
6
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

Irritant / corrosive response data:
No individual results are available. A result of non-irritating according to the EC criteria is reported.

Any other information on results incl. tables

Mean results across all six rabbits at observation time shown with standard deviation in brackets:

Observation time

1h

24h

48h

72h

Erythema scores (standard deviation)

2.33 (0.80)

0.50 (0.55)

0.50 (0.55)

0.67 (0.57)

These values do not meet the criteria for classification.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a study in rabbits 2 -butoxyethyl acetate was tested according to an EU protocol for irritancy testing. Whilst some redness persisted to the end of the observation, the results that were reported did not meet the criteria for classification as an irritant. Sufficient details are available across three publications to be able to judge the result as reliable.

Synopsis:

Not irritating