2-butoxyethanol

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. Not to GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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.