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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Cited as Directive 84/449/EEC, B.6
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
3-cyano-3,5,5-trimethylcyclohexanone
EC Number:
411-490-4
EC Name:
3-cyano-3,5,5-trimethylcyclohexanone
Cas Number:
7027-11-4
Molecular formula:
C10 H15 N O
IUPAC Name:
3-cyano-3,5,5-trimethylcyclohexanone
Details on test material:
- Lot No.: 22298/133
- Purity: > 99.5%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 267-317 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
Intradermal induction: 0.1 ml of 1% formulation in olive oil
Percutaneous induction: 0.3 g (as 75% formulation in olive oil)
Challenge: 0.15 g (as 50% formulation in olive oil)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Intradermal induction: 0.1 ml of 1% formulation in olive oil
Percutaneous induction: 0.3 g (as 75% formulation in olive oil)
Challenge: 0.15 g (as 50% formulation in olive oil)
No. of animals per dose:
Control group: 5
Test group: 10
Details on study design:
RANGE FINDING TESTS:
Amount applied:
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). In the case of liquids the test filter paper strip was soaked in the test substance resp. test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance resp. test substance formulation.
Exposure period:
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application:
- flank, respective on the same area
Number of test animals:
- 4 per test concentration
Readings:
- about 24 and 48 h after the beginning of application

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: 2
- Test groups: 1: A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9%aqueous NaC1-solution in a ratio of 1:1 B) middle row: 2 .injections each of 0.1 ml of the test substance formulation C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1) with test substance
- Control groups: 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site: Shoulder
- Frequency of applications: once
- Duration: 7 days (reading after 24 h)
- Concentrations: 0.1 ml of 1% formulation in olive oil

Percutan
- No of exposures: 1
- Test group: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). The filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance formulation.
- Control groups: The control groups were treated analogously to the test group but only with the solvent without the test substance.
- Site: Shoulder
- Frequency of application: once
- Duration: 48 h
-Concentration: 0.3 g (as 75% formulation in olive oil)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 (after intradermal induction)
- Exposure period: 24 h
- Test groups: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing the bandage consists of rubberized linenpatches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance formulation.
- Control group: treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle. Control group 2 only received olive oil DAB 9.
- Site: flank
- Concentrations: 0.15 g (as 50% formulation in olive oil)
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch


OTHER:
Challenge controls:
yes, (control group 2)
Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitro-benzol

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.15 g (as 50% formulation in olive oil)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.15 g (as 50% formulation in olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.15 g (as 50% formulation in olive oil)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.15 g (as 50% formulation in olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Negative control group 1
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Negative control group 1
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Negative control group 2
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Negative control group 2
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
edema and erythema of varying degree
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: edema and erythema of varying degree.

Applicant's summary and conclusion