Registration Dossier
Registration Dossier
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EC number: 251-336-1 | CAS number: 33007-83-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 July 2002 - 4 August 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pentaerythritol tetrakis(3-mercaptopropionate)
- EC Number:
- 231-472-8
- EC Name:
- Pentaerythritol tetrakis(3-mercaptopropionate)
- Cas Number:
- 7575-23-7
- Molecular formula:
- C17H28O8S4
- IUPAC Name:
- 3-[(3-sulfanylpropanoyl)oxy]-2,2-bis{[(3-sulfanylpropanoyl)oxy]methyl}propyl 3-sulfanylpropanoate
- 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: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.4 ± 0.1 kg.
- Housing: individually in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2002-07-30 To: 2002-08-04
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 3 min / 4 h (left / right flank)
- Observation period:
- 5 days
- Number of animals:
- 1+2
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item was wiped off by means of a dry cotton pad
- Time after start of exposure: 3 min / 4 h (left/right flank)
SCORING SYSTEM:
0-4, as laid down in OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: 3 min exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 3-min exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: 4-h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-h exposure
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- PETMP is not irritating to skin.
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