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Description of key information

Carbon Black (XPB 295) was not a skin sensitiser in guinea pigs (Buehler test performed according to OECD guideline 406). In humans, no cases of allergies were reported.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04/2003 to 10/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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 group
Dose level:
50% in sterile water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
dark coloration at treated sites
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in sterile water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: dark coloration at treated sites.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% in sterile water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
dark coloration at treated sites
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in sterile water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: dark coloration at treated sites.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Carbon Black XPB 295 was not sensitising in guinea pigs (Buehler test performed according to OECD guideline 406)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Carbon black has not been tested in animals for sensitisation effects on the respiratory tract. In humans, no cases of allergies were reported.

Justification for classification or non-classification

Not classifiable according to the criteria as laid down in the CLP Regulation