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Toxicological information

Skin sensitisation

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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:
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:
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 OECD/EU testing guideline 406

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
epidermal induction with 50% of the test material in sterile water
Challenge
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

Results and discussion

Positive control results:
60% response

In vivo (non-LLNA)

Resultsopen allclose all
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.

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)