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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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Diisopropyl ether
- Physical state: liquid
- Analytical purity: 99.5%
- Lot/batch No.: 09062392
- Expiration date of the lot/batch: June 2010
- Storage condition of test material: Room Temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 to 12 weeks
- Weight at study initiation: 2.26 to 3.07 kg
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum, SDS-C15
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions were appreciated 1, 24, 48, and 72 hours after removal of the patch
Number of animals:
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.
Details on study design:
TEST SITE
- Area of exposure: 6 square centimetre patch
- Type of wrap if used: semi-occlusive dressing secured with surgical adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of patch treated area was rinsed with distilled water.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Local dermal irritation was assessed using the prescribed OECD numerical system

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation
(injuries in depth) preventing erythema reading 4



Oedema formation:

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending
beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 3 to 6 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 to 6 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 to 6 days
Irritant / corrosive response data:
A very slight to well defined erythema, associated with a very slight to slight oedema, was noted on the treated area of all animals, 1 hour after patch removal. The oedematous reactions were totally reversible between day 3 and day 6 and the erythematous reactions were totally reversible on day 6.
Other effects:
Regarding the cutaneous aspect, a slight dryness was noted on day 3 or day 6 and was totally reversible on day 10 in two animals and remained on day 14 in the other one.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP (EC 1272/2008)
Conclusions:
The results obtained in this in-vivo study conclude that the test item diisopropyl ether does not have to be classified for skin irritation and is therefore, considered not to be a skin irritant.