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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 guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
EC Number:
923-108-8
IUPAC Name:
2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate

Test animals

Species:
rabbit
Strain:
other: albino, CRL:KBL(NZW)BR
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: females
- Source: Charles River, Kißleg, Germany
- Age at study initiation: young adult animals
- Diet and water: ad libitum
- Acclimation period: at least 5 days

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The surrounding untreated skin served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Until changes had completely subsided, however for not more than 14 days after application.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² on the dorso-lateral areas of the trunk of each animal
- Type of wrap if used: non-irritant tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful washing with water without altering the existing response or the integrity of the epidermis
- Time after start of exposure: 4 h

SCORING SYSTEM: as specified by Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
The control areas did not show any abnormal findings.
There were no systemic intolerance reactions.

Applicant's summary and conclusion

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

A well-conducted Acute Dermal Irritation/ Corrosion test (OECD 404) was performed on rabbits with the test substance. Under the conditions of the test no signs of skin irritation could be observed 24, 48 and 72 hours after exposure (4 hours). There were no systemic intolerance reactions.

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