Registration Dossier
Registration Dossier
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EC number: 277-288-1 | CAS number: 73138-39-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Aug 2004 - 27 Sep 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- lack of details (test substance, animals, housing, methods)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- no rationale for in vivo testing, no initial testing with one animal
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- December 29th, 1992
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des produits chimiques, Paris, Republique Francaise
Test material
- Reference substance name:
- Fatty acids, coco, esters with 1,3-butanediol
- EC Number:
- 277-288-1
- EC Name:
- Fatty acids, coco, esters with 1,3-butanediol
- Cas Number:
- 73138-39-3
- Molecular formula:
- not applicable, the substance is UVCB
- IUPAC Name:
- Fatty acids, coco, esters with 1,3-butanediol, UVCB
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not stated
- Weight at study initiation: 2.32 kg - 2.56 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: not stated
- Water: not stated
- Acclimation period: 7-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 60-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
IN-LIFE DATES: 31 Aug 2004 - 04 Sep 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: not specified;
- Remarks:
- undamaged skin area of the right flank
- 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
- Concentration (if solution): as supplied by sponsor - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Right flank. Size of skin area not specified.
- % coverage: not stated
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated
OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the patch
SCORING SYSTEM:
Erythema and Eschar formation: grading scales 0 to 4 (no, slight, definite, moderate, severe)
Oedema: grading scales 0 to 4 (no, slight, slight with contour, moderate, severe)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No cutaneous reactions (erythema and oedema) were observed at any examination time in any of the three animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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