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Skin sensitisation

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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: Acceptable, well-documented study report equivalent or similar to EU Method B6: GLP.
Justification for type of information:
The Buehler skin sensitisation test is a scientifically valid method for assessing skin sensitisation potential. As the data exists and is adequate for hazard assessment, perfoming a new LLNA test is not scientifically justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The Buehler skin sensitisation test is a scientifically valid method for assessing skin sensitisation potential. As the data exists and is adequate for hazard assessment, perfoming a new LLNA test is not scientifically justified.

Test material

Constituent 1
Reference substance name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
Molecular formula:
CnH2n+2O2. n=24-33
IUPAC Name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
Details on test material:
- Name of test material (as cited in study report): Vammar D10
- Substance type: liquid
- Physical state: clear, oily
- Composition of test material, percentage of components: alcohols C9-C10 (0-6%), dimers C18-C22 (83-93%), trimers (6-11%)
- Storage condition of test material: room temperature
Specific details on test material used for the study:
The test substance was prepared prior to each application on the day of dosing in Alembicol D (a product of coconut oil, supplied by Alembic Products, Saltney, Chester, England).

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 311-366 g
- Housing: groups of 5
- Diet (e.g. ad libitum): vitamin C enriched guinea pig diet FD1 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
coconut oil
Concentration / amount:
0.5 ml of Vammar D10, 75% v/v in Alembicol D
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
coconut oil
Concentration / amount:
0.5 ml of Vammar D10, 75% v/v in Alembicol D
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: left shoulder region
- Frequency of applications: once on days 1, 8, and 15
- Duration: 24 hours
- Concentrations: 0.5 ml as a 75% v/v in Alembicol D


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 12 weeks after the final induction
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: right flank
- Concentrations: 0.5 ml as a 75% v/v in Alembicol D
- Evaluation (hr after challenge): 24, 48, and 72 hours post removal


POSITIVE CONTROL STUDY
The sensitivity of the guinea-pig strain used was checked periodically by testing facility with formalin.
Positive control substance(s):
yes
Remarks:
formalin

Results and discussion

Positive control results:
A formalin study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Induction (all three exposures)
Group:
negative control
Dose level:
0 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of erythema or edema
Remarks on result:
other: Reading: other: Induction (all three exposures). Group: negative control. Dose level: 0 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of erythema or edema.
Reading:
other: Induction (all three exposures)
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of erythema or edema
Remarks on result:
other: Reading: other: Induction (all three exposures). Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of erythema or edema.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of erythema or edema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of erythema or edema.
Reading:
other: Induction (all three exposures)
Group:
positive control
Dose level:
30% aqueous solution of formalin
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Remarks:
A positive control study, conducted by testing facility using Formalin, demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Not sensitising
Executive summary:

In this study, 20 guinea pigs were tested with the registered substance under EU Method B6 to assess the skin sensitization potential. Three occlusive inductions of 0.5 ml the registered substance as a 75% v/v solution on Alembicol D were administered. After a 2 week rest period, a single 6 hour challenge application was applied. Dermal observations were made at 24, 48 and 72 hours following this exposure. At no point during the course of the study were there any clinical observations of erythema or edema. It is concluded that the registered substance is not a skin sensitizing agent.