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EC number: 923-108-8 | CAS number: 1187576-42-6
Skin irritation / corrosion
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:
- 2 010
- 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
- Reference substance name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
- EC Number:
- 923-108-8
- Cas Number:
- 1187576-42-6
- IUPAC Name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
Constituent 1
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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