Registration Dossier
Registration Dossier
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EC number: 233-482-8 | CAS number: 10193-99-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non guideline, non-GLP, but with sufficient reporting detail to accept the positive result
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- A reliability check was not included; this is not necessary in light of the positive result. The test material was not characterised.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An guinea pig maximisatoin test is used. Due to animal welfare no LLNA test system was conducted.
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
- Details on test material:
- not reported
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction: 1% (intradermal), 20% (topical)
Challenge: 0.5, 1, 5, 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction: 1% (intradermal), 20% (topical)
Challenge: 0.5, 1, 5, 10%
- No. of animals per dose:
- 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- other: not reported
- Reading:
- other: two readings combined
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Reading:
- other: two readings combined
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Reading:
- other: two readings combined
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Reading:
- other: two readings combined
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 20
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- PETMP is a strong sensitizer in the GPMT
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