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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethoxy-2-methylpropane
EC Number:
211-309-7
EC Name:
2-ethoxy-2-methylpropane
Cas Number:
637-92-3
Molecular formula:
C6H14O
IUPAC Name:
2-ethoxy-2-methylpropane
Details on test material:
- Name of test material (as cited in study report): ETBE
- Physical state: colourless liquid
- Analytical purity: 95.8%
- Lot/batch No.: 93050601

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ESD
- Age at study initiation: about 3 months old
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: individually
- Diet: 150 g/animal/day
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +- 3
- Humidity (%): >45
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml, 100 %
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours, 7 days
Number of animals:
3 males
Details on study design:
0.5 ml ETBE was applied to a gauze pad (2.5 x 2.5 cm) which was held in contact with clipped healthy skin under a semi-occlusive dressing for 4 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+48+72 hr
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24+48+72 hr
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Under the conditions of the test, ETBE was not irritating to the skin.
Other effects:
One animal showed slight desquamation at the application site on day 7.

Applicant's summary and conclusion