Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions: no positive control group (not required by 1981 version of guideline).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Reference Type:
other: OECD SIDS
Title:
3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
Author:
OECD SIDS
Year:
2003
Bibliographic source:
SIDS Initial Assessment Report for SIAM 16

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
3,5,5-trimethylcyclohex-2-enone
EC Number:
201-126-0
EC Name:
3,5,5-trimethylcyclohex-2-enone
Cas Number:
78-59-1
IUPAC Name:
3,5,5-trimethylcyclohex-2-en-1-one
Details on test material:
- Analytical purity: not reported

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino, Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen (DE)
- Weight at study initiation: 314.2 g (mean)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Induction: 10% (in Freund's Complete Adjuvant (FCA))
Challenge: undiluted
2nd challenge: undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 10% (in Freund's Complete Adjuvant (FCA))
Challenge: undiluted
2nd challenge: undiluted
No. of animals per dose:
20 (test)
10 (control)
Details on study design:
1st application: Induction 10 % intracutaneous
2nd application: Challenge undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: 1st and 2nd reading
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 1st and 2nd reading. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information