Registration Dossier
Registration Dossier
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EC number: 204-876-7 | CAS number: 128-04-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 360-446 g - Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- shown in details
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- shown in details
- No. of animals per dose:
- 10 (control group: 5)
- Details on study design:
- PILOT STUDY
Pre-test on intradermal application on two guinea pigs with 1% and 5% SDDC.
Pre-test on topical application on two guinea pigs with 25%, 50% and 75% SDDC.
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL
- Time Schedule: Day 0
- Exposure period: -
- Concentrations: 5%
- Volume: 0.1 mL/injection site
INDUCTION EXPOSURE - EPICUTANEOUS
- Time Schedule: Day 7
- Exposure period: 48 h
- Concentrations: 50%
- Volume: saturated filter paper patch (40 x 20 mm)
B. CHALLENGE EXPOSURE
- Time Schedule: Day 21
- Exposure period: 24 h
- Concentrations: 50% and 75%
- Evaluation (hr after challenge): 24 and 48 h after application
SCORING SYSTEM
0 - no reaction
0.5 - very faint erythema, usually non-confluent
1 - faint erythema usually confluent
2 - moderate erythema
3 - severe erythema with or without oedema
- Challenge controls:
- distilled water
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- The positive control alpha-hexylcinnamaldehyde (5% in mineral oil) elicited an incidence of sensitisation of 40-50%.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 6
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 6.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 2.0. Total no. in groups: 9.0.
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Since the skin reactions observed at 24 h after challenge did not persist after 48 h, the proportion of truly sensitized animals is only 22%. This is not sufficient for classification as a skin sensitizer.
Reference
Table 7.4.1-1 Skin sensitisation scores - SDDC |
||
Skin reactions after challenge application of 50% SDDC in distilled water (left flank) |
||
Time point |
SDDC-induced animals |
Vehicle-induced animals |
24 h |
5/9 |
0/5 |
48 h |
0/9 |
0/5 |
Skin reactions after challenge application of 75% SDDC in distilled water (right flank) |
||
24 h |
6/9 |
0/5 |
48 h |
2/9 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
SDDC was tested in a Guinea Pig Maximisation Test. The ratio of sensitised animals was 2/9 at the 48-h reading.
Migrated from Short description of key information:
SDDC was negative in a GPMT (OECD 406).
Justification for selection of skin sensitisation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
SDDC was tested in a Guinea Pig Maximisation Test. The ratio of sensitised animals (2/9) does not fulfil the 30% criterion for adjuvant tests of DSD and CLP for classification as skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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