Registration Dossier
Registration Dossier
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EC number: 215-609-9 | CAS number: 1333-86-4
Endpoint summary
Administrative data
Description of key information
The potential of surface treated carbon black (XPB 295) to induce and elicit delayed hypersensitivity was tested in guinea pigs using the Buehler method (in accordance with the OECD test guideline 406) and GLP conditions (Degussa AG 2003). A group of 20 test animals was induced by topical application of a 50% aqueous suspension of the test material once a week for three weeks and challenged two weeks later with the same test concentration. Application sites showed dark coloration, but none of the treated animals had a sensitisation reaction. A “reliability check” was performed in parallel to the afore mentioned study in a group of animals with alpha-cinnamic aldehyde. 60% of this group showed a sensitisation reaction, and the test system was therefore considered to be valid. The study is reliable without restrictions (reliability code 1).
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:
- weight of evidence
- Study period:
- 04/2003 to 10/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study performed before adoption of the OECD TG 429 (LLNA method)
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- in accordance with the OECD/EU testing guideline 406
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- epidermal induction with 50% of the test material in sterile water
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50% of the test material in sterile water
- No. of animals per dose:
- 20 animals in the test group, 10 animals in the control group
- Details on study design:
- in accordance with the OECD/EU testing guidelines
- Challenge controls:
- in accordance with the OECD/EU testing guidelines
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- 60% response
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- dark coloration of treatment sites
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- dark coloration of treatment sites
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- α-Hexylcinnamaldehyde
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- sensitisation effects in 6/10
- Remarks on result:
- positive 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:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Carbon Black XPB 295 was not sensitising in guinea pigs (Buehler test performed according to OECD guideline 406)
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In humans, no cases of allergies have been reported to the responsible occupational physicians within the carbon black manufacturing industry (ICBA 2016).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Surface treated carbon black has not been tested in animals for sensitisation effects on the respiratory tract.
Justification for classification or non-classification
Not classifiable according to the criteria as laid down in the CLP Regulation
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