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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. Not to GLP.

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butoxyethanol
EC Number:
203-905-0
EC Name:
2-butoxyethanol
Cas Number:
111-76-2
Molecular formula:
C6H14O2
IUPAC Name:
2-butoxyethanol
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 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
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: average of 24, 48, 72 hour observations
Irritation parameter:
edema score
Basis:
mean
Score:
0.13
Max. score:
4
Reversibility:
not fully reversible within: 48 hours
Remarks on result:
other: average of 24, 48, 72 hour observations
Irritation parameter:
other: maximum degree of eschar formation
Basis:
other: maximum
Score:
2
Remarks on result:
other: Over 24, 48, 72 hour observations
Irritant / corrosive response data:
no further data other than described above
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance shows slight to moderate erythema but only very slight edema.
Executive summary:

In a well reported study in rabbits carried out to an EU protocol for irritancy testing, 2 -butoxyethanol showed mild to moderate irritation to the skin. This was manifest primarily as erythema rather than odema. The effects were persistent and still visible (albeit very slight) at the end of the 14 day observation period

Synopsis:

Irritating under both the DSD and the EU GHS regulation. Effects are not severe enough in their own right to trigger classification but are based on persistency of effects and the end of the 28 day observation period.

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