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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 July 2015 - 19 August 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD guideline conformant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7,11-trimethyldodecyn-3-ol
EC Number:
216-510-3
EC Name:
3,7,11-trimethyldodecyn-3-ol
Cas Number:
1604-35-9
Molecular formula:
C15H28O
IUPAC Name:
3,7,11-trimethyldodec-1-yn-3-ol
Details on test material:
- Name of test material (as cited in study report): 3,7,11-trimethyldodecyn-3-ol
- Test item No.: 05/0025-2
- Physical state: colorless, clear liquid
- Analytical purity: 9.8%
- Lot/batch No.: 40637247G0
- Expiration date of the lot/batch: 29 March 2016
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HARLAN, Kreuzelweg 53, 5961 NM HORST, The Netherlands
- Age at study initiation: 3-4 weeks
- Weight at D0 of study: 263.4 - 270.4 g
- Housing: in groups of 2
- Diet: SAFE 106 ad libitum
- Water: ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (+/- 3)
- Humidity (%): 30-70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Animals in treated group were sensitized and challenged with 0.5ml of the test item diluted at 75% in liquid paraffin (MNIC determined in pre-study),
control animals were treated with 0.5ml of liquid paraffin.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Animals in treated group were sensitized and challenged with 0.5ml of the test item diluted at 75% in liquid paraffin (MNIC determined in pre-study),
control animals were treated with 0.5ml of liquid paraffin.
No. of animals per dose:
Total animals: 30
Group 1 (negative control): 10 female guinea pigs
Group 2 (treated with test substance): 20 female guinea pigs
Details on study design:
RANGE FINDING TESTS:
A preliminary study was carried out to dertermine the MNIC. Three guinea pigs were treated with concentrations of 100%, diluted at 75%, 50%, and 25%of test substance in liquid paraffin. Application was performed epicutaneously under occlusive dressing for 6 hours. Cutaneous reaction was
determined 24h and 48h after removal of occlusive dressings. 24 hours after removal of the patches, a discrete erythema (grade 1) in two animals (2/3) was noted at the tested concentration of 100%. No cutaneous reaction was noted in the other animal 48 hours after the removal of the patches, one of these animals still showed discrete erythema, while the other one exhibited dryness of the skin.
24 and 48 hours after removal of the patches, no cutaneous reaction was noted at the other tested concentrations 75%, 50% and 25%.
In view of these results, the concentration selected was 100% for the 3 inductions of the main study and the concentration selected was 75% (MNIC) for the challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure at D0, D7, D14
- Site: inter-scapular zone
- Duration: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in contact
with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: 100% test substance (treated group), liquid paraffin (control group)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: D28
- Site: dorso-lumbar zone
- Exposure period: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in
contact with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: test item diluted at 75% in liquid paraffin (MNIC) on the left flank or liquid paraffin on the right flank
- Evaluation (hr after challenge): 24h, 48h after removal of occlusive dressing

Grading was perfomed according to OECD 406:
0 = No visible change
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling

The number of animals showing visible cutaneous reactions were determined and recorded at 24 and 48 hours after challenge.
The classification "sensitising" results if at least 15% of test animals showed cutaneous reactions at the time of evaluation. The evaluation is based on
the criteria of the OECD Harmonized Integrated Classification System in place on the date of report signature.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Discrete erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Induction phase:

         Animals showing cutaneous reactions
   1st induction  2nd induction  3rd induction
 Control group (10 animals)  0  0  0
 Treated group  0  0  0

 

Challenge phase:

In the treated group (treatment concentration 75% of test item), a discrete erythema was noted in only one animal (1/20) at the reading time 24 hours. No macroscopic cutaneous reactions attributable to allergy were observed 48 hours after the removal of the occlusive dressing.

In the control group, no cutaneous reactions were observed at 24 or 48 hours after removal of occlusive dressing.

No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the area treated with liquid paraffin.

                Grading scale    
 Groups  Reading time  Concentrations  0  1  2  3  % positive responses  % of animals sensitized
 Control           24 hours 75%   10  0  0  0  0  
 48 hours 75%  10  0  0  0  0  
 24 hours 0%  10  0  0  0  0  
 48 hours 0%  10  0  0  0  0  
 Treated           24 hours 75%  19  1  0  0  5  5
 48 hours 75%  20  0  0  0  0  0
 24 hours 0%  20  0  0  0  0  0
 48 hours 0%  20  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information

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