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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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:
other: OECD Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
Carbon black
EC Number:
215-609-9
EC Name:
Carbon black
Cas Number:
1333-86-4
IUPAC Name:
methane
Details on test material:
CARBON BLACK XPB 295

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
in accordance with the current OECD/EU testing guidelines

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
epidermal induction with 50% of the test material in sterile water; epidermal challenge with 50% of the test material in sterile water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
epidermal induction with 50% of the test material in sterile water; epidermal challenge with 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 current OECD/EU testing guidelines
Challenge controls:
in accordance with the current OECD/EU testing guidelines
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Study design: in vivo (LLNA)

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
not performed

Results and discussion

Positive control results:
60% response

In vivo (non-LLNA)

Resultsopen allclose all
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 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.
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 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.

Applicant's summary and conclusion

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)