Registration Dossier
Registration Dossier
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EC number: 405-520-5 | CAS number: 95235-30-6 D-8; DD-8
Endpoint summary
Administrative data
Description of key information
D-8 was tested for delayed hypersensitivity in the guinea-pig according to the EU Guideline B.6 and OECD 406. D-8 did not produce any evidence of delayed contact hypersensitivity.
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:
- 1986-05-02 to 1986-07-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA study was conducted as an in vivo study according to OCED 406 was conducted in 1989, before the first version of the LLNA (OECD 429) was issued in 2002.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall; Newchurch, Staffordshire, England;
- Age at study initiation: not indicated;
- Weight at study initiation: mean 430 - 440 g;
- Housing: suspended cages with wire mesh floors;
- Diet: Vitamin C-enriched Guinea pig diet F.D.1.; Supplier: Special Diets Services Limited; ad libitum;
- Water: tap water, ad libitum;
- Acclimation period: not indicated;
ENVIRONMENTAL CONDITIONS
- Temperature: approx. 21 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: approx. 15 air changes/hour
- Photoperiod: 12 hours light/12 hours dark
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Intradermal injection: 7.5 % w/w in Alembicol D;
Topical application: 50 % w/w in Alembicol D; - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 50 % and 20 % w/w in Alembicol D;
- No. of animals per dose:
- 20 test animals
20 control animals - Details on study design:
- The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pig maximisation test described by B. Magnusson and A.M. Kligman.
- Positive control substance(s):
- no
- Positive control results:
- not tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- D-8 was tested for delayed hypersensitivity in the guinea-pig according to the EU Guideline B.6 and OECD 406. D-8 did not produce any evidence of delayed contact hypersensitivity.
- Executive summary:
D-8 was tested for delayed hypersensitivity using the Magnusson-Kligman Test in guinea pigs. Test animals were induced by intradermal (7.5% w/w) and topical application (50% w/w) of D-8 in Alembicol 8, a coconut oil derived solvent for dermal applications. Two weeks after the induction period, the animals were challenged by dermal application of the test item. The evaluation after 24, 48 and 72 hours after removal of the test substance showed no evidence of delayed hypersensitivity caused by the test item. In conclusion, D-8 was considered non-sensitizing in contact with skin.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
D-8 was tested for delayed hypersensitivity using the Magnusson-Kligman test in guinea pigs. Test animals were induced by intradermal (7.5% w/w) and topical application (50% w/w) of D-8 in Alembicol 8, a coconut oil derived solvent for dermal applications. Two weeks after the induction period, the animals were challenged by dermal application of the test item. The evaluation after 24, 48 and 72 hours after removal of the test substance showed no evidence of delayed hypersensitivity caused by the test item. In conclusion, D-8 was considered non-sensitizing in contact with skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) No 2019/521.
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