Registration Dossier

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