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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 substance(s):
yes
Remarks:
formalin

Results and discussion

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 group
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 group
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.

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 test with CAS# 98072-31-2 under EU Method B6 to assess the skin sensitization potential.  Three occlusive inductions of 0.5 ml CAS# 98072-31-2 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 CAS# 98072-31-2 is not a skin sensitizing agent.