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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3,4,9-tetrahydro-1H-carbazol-3-one
EC Number:
610-619-3
Cas Number:
51145-61-0
Molecular formula:
C12H11NO
IUPAC Name:
2,3,4,9-tetrahydro-1H-carbazol-3-one

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
Intradermal injection: 1 % w/v in 5 % Acetone in Alembicol D
Topical application: 80 % w/v in acetone
Challenge application: 80 and 40 % in acetone
Challengeopen allclose all
Route:
intradermal and epicutaneous
Concentration / amount:
Intradermal injection: 1 % w/v in 5 % Acetone in Alembicol D
Topical application: 80 % w/v in acetone
Challenge application: 80 and 40 % in acetone
No. of animals per dose:
10 test animals and 5 control guinea-pigs

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40 % w/v in acetone
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 % w/v in acetone. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40 % w/v in acetone
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 % w/v in acetone. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
80 % w/v in acetone
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 80 % w/v in acetone . No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
80 % w/v in acetone
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 80 % w/v in acetone. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 % w/v in acetone
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 % w/v in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
80 % w/v in acetone
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 80 % w/v in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information