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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: The study was conducted according to an appropriate test protocol and in compliance with GLP. The study is read-across from 1-decanol (CAS 112-30-1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
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): Alfol 10

- Physical state: colourless liquid, sweet pungent odour

- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elm Hill Breeding Labs., Chelmsford, MA
- Age at study initiation: young adult
- Weight at study initiation: 357-449g
- Housing: group-housed in suspended stainless steel caging with mesh floors or plastic perforated bottom caging.
- Diet: Pelleted Purina Guinea Pig Chow ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 4-17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 56-79
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
0.4ml of undiluted test material was used for the induction phase.
0.4 ml of a 25% w/w mixture of the test substance in mmineral oil was used for the challenge phase.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
0.4ml of undiluted test material was used for the induction phase.
0.4 ml of a 25% w/w mixture of the test substance in mmineral oil was used for the challenge phase.
No. of animals per dose:
Preliminary irritation group:4
Test group: 10
Naive control group: 10
Details on study design:
INDUCTION PHASE:
Once each week for three weeks, 0.4ml of the undiluted test substance was applied to the left side of each test animal using an occlusive 25 mm Hill Top CHamber. The chambers were secured in place and wrapped with adhesive tape to avoid dislocation of the chambers and to minimize loss of the test substance. After the 6
h exposure period, the chambers were removed and the test sites were gently cleansed with a 3% soap solutionh followed by tap water using a clean paper towel to remove any residual test substance. Approximately 24 and 48 hours after each induction application, readings were made of local reactions (erythema).

CHALLENGE PHASE:
Twenty-seven days after the first induction dose, 0.4 ml of a 25% w/w mixture of the test substance in mineral oil was applied to a naive site on the right side of each animal as a challenge dose, using the procedures described above. These sites were evaluated for a sensitization response (erythema) approximately 24 and 48 hours after the challenge application.
Challenge controls:
In addition to the test animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated withe mineral highest non irritating concentration of the test substance at challenge only.
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde technical

Results and discussion

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.4ml 25% w/w mixture of substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
very faint erythema present in some of the animals
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4ml 25% w/w mixture of substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema present in some of the animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the available information, the test substance was found not sensitizing to guinea pig skin.