Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-07-24 to 1996-08-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,5-trimethylcyclohexan-1-one
EC Number:
212-855-9
EC Name:
3,3,5-trimethylcyclohexan-1-one
Cas Number:
873-94-9
Molecular formula:
C9H16O
IUPAC Name:
3,3,5-trimethylcyclohexan-1-one
Details on test material:
3,3,5-trimethylcyclohexanone of Hüls AG, purity 98.7 % (GC-FID area), produced April 1995, ID No. 0637/81 736, internal No. 0166
Result of purity check: 96.7 % GC-FID area

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Dunkin-Hartley, Pirbright White, Hsd/Win:DH (SPF)
- Sex: female
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Age: healthy young adults
- Weight at study initiation: 342 g (mean test); 345 g (mean control)
- Controls: 10 animals; treatment: vehicle
- Diet: ad libitum, special diet for guinea pigs, SSniff G
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil
Concentration / amount:
1st application: Induction undiluted occlusive epicutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Induction undiluted occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil
Concentration / amount:
1st application: Induction undiluted occlusive epicutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Induction undiluted occlusive epicutaneous
No. of animals per dose:
20 test
10 control
Details on study design:
ADMINISTRATION/EXPOSURE 
- Induction schedule: 3 identical inductions on days 0, 7, and 14:   
6 hour occlusive patch (left side), 0.3 ml undiluted; then removal of  residual test material   
assessment 30 hours after each administration
- Challenge schedule: day 28   two 6 hour occlusive patches (right side), one with 0.3 ml test  substance and one with vehicle   
subsequent removal of residual test material   
assessments 30 and 54 hours after administration
- Concentrations used for challenge: undiluted (100 %)
- Positive control:   2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)  
Bühler test with 10 test and 5 control animals   
Occlusive epicutaneous induction with 50 % in petrolatum   
Occlusive epicutaneous challenge with 50 % in petrolatum
EXAMINATIONS
- Grading system: as usual for skin irritation, 0-8 scores possible
- Pilot study: dermination of slightly and not skin irritating  concentrations   
dermal concentrations: 5; 25; 50; 100 % w/w   3 animals each with 4 different concentrations (0.3 ml each) at  different sites   
6 hour occlusive patch test followed by removal of residual test  material   assessment of dermal reactions 30 and 54 hours after administration
- Additional (and identical except for increased body weights) pilot  study during week 4; reason: Increase in body weight might cause  differences in  skin sensitivity
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4)

Results and discussion

Positive control results:
Bühler test with 10 test and 5 control animals  (separate test) with 2-mercaptobenzothiazol
Occlusive epicutaneous induction with 50 % in petrolatum   
Occlusive epicutaneous challenge with 50 % in petrolatum
reading 30 h and 54 h post application: 30 % positive reactions

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
30
Group:
test chemical
Dose level:
induction: 100 %; challenge: 100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: induction: 100 %; challenge: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test chemical
Dose level:
induction: 100 %; challenge: 100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: induction: 100 %; challenge: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
induction: vehicle; challenge: 100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: induction: vehicle; challenge: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
induction: vehicle; challenge: 100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: induction: vehicle; challenge: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

RESULTS OF PILOT STUDY: None of the applied test substance concentrations  caused primary skin irritation in any of the two 

pilot studies 30 or 54  hours after administration.
RESULTS OF TEST
- Sensitization reaction: No signs of skin irritation were observed in  the application areas of test and control animals 30 and 54 hours 

after  administration.
- Clinical signs: No signs of systemic toxicity were observed.
  1st, 2nd, and 3rd induction: No signs of skin irritation were observed  in the application areas of test and control animals 30 hours 

after  administration.
- Positive control: 3/10 test animals positive 30 hours after challenge,  no control animal positive
- Other: The overall mean body weight increase of 227 g (test group) /  217 g (control group) is in the expected range: no treatment 

related  effect.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this OECD 406 study 3,3,5-trimethylcyclohexanone showed no dermal sensitization in female guinea pigs.
Executive summary:

The skin sensitizing properties of 3,3,5-trimethylcyclohexanone were assessed in a buehler test according to OECD 406. Twenty female guinea pigs were treated with 3 identical inductions on  days 0, 7, and 14 (occlusive epicutaneous) of undiluted 3,3,5-trimethylcyclohexanone. Ten control animals were similary treated, but with vehicle alone. Two weeks after the induction treatment all animals were challegend with undiluted substance and the vehicle. Under the conditions of this test the test item 3,3,5-trimethylcyclohexanone showed no dermal sensitization in female guinea pigs.

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