Registration Dossier
Registration Dossier
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EC number: 442-520-4 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 24th to August 30th, 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 406 (Skin Sensitisation)
- Version / remarks:
- Adopted July 17th, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Adopted July 30th, 1996
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A Buehler test was avaliable
Test material
- Reference substance name:
- Yellow 6314-PPT
- IUPAC Name:
- Yellow 6314-PPT
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: IbM: GOHI
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- 25%
- Day(s)/duration:
- 1st, 8th, 15th day / 6h
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- 25%
- Day(s)/duration:
- 29th day / 6h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in the test group: 20
Number of animals in the negative control group: 10
Number of animals in the irritation screen: 4 - Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde. Challenge: 20 test animals (males), 10 control animals (males); lrritation Screen: 4 animals (males). Performed from July 23rd, 2002 to August 29th, 2002
Results and discussion
- Positive control results:
- 19 (at the 24-hour reading) and 17 (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent erythema after the challenge treatment with the highest tested non-irritating concentration of Alpha-Hexylcinnamaldehyde at 5 % in PEG 300.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5 % in PEG
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5 % in PEG 300
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
There were no deaths during the course of the study, hence no necropsies were performed. No symptoms of systemic toxicity were observed in the animals.
The second and third induction sites could not be evaluated due to the slight pigmentation of the skin still present from the first induction and the additional induction applications.
After challenge, animals were depilated 3 hours prior to the 24-hour reading to clean the skin area from the staining produced by the test item and to facilitate the reading of the skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not skin sensitizer.
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