Registration Dossier
Registration Dossier
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EC number: 800-765-8 | CAS number: 1424149-03-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-07-02 to 1991-07-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; well-performed and well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
- EC Number:
- 800-765-8
- Cas Number:
- 1424149-03-0
- Molecular formula:
- C21H40NO4.1/2Na.1/2C6H15NO3
- IUPAC Name:
- sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Body weight at start of experiment: 2,8 - 3,2 kg
Age: 3 - 5 month
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4h
- Observation period:
- up to 14 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin irritation potential of pentapropylensuccinic anhydride, EA/Na/TEA was investigated according to the OECD Guideline 404. Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts should be classified as R38.
- Executive summary:
The skin irritation potential of Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated according to the OECD Guideline 404. Erythema in three rabbits up to the score of 3 and oedema in one rabbit up to the score of 1 was obtained for readings at 24, 48 and 72 hours. All effects were reversible within 7 days. Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts should be classified as R38.
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