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Toxicological information

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
Study period:
31st of July 2008 to 4th of September 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.

Test material

Constituent 1
Chemical structure
Reference substance name:
Decan-1-ol
EC Number:
203-956-9
EC Name:
Decan-1-ol
Cas Number:
112-30-1
Molecular formula:
C10H22O
IUPAC Name:
decan-1-ol
Test material form:
liquid

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)

Induction
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.
Challenge
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 with 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)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.4 ml, 25% w/w mixture of the test substance in mineral oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
very faint erythema (0.5) present in 5 of 20 of the animals (not considered as positive reaction)
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 ml, 25% w/w mixture of the test substance in mineral oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Very faint erythema (0.5) present in 2 of 20 of the animals (not considered as positive reaction)
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.4 ml, 25% w/w mixtre of the test sbstance in mineral oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Very faint erythema present (0.5) was noted for 1 out of 10 control sites at 24 hours after challenge. Irritation was clear from the test site by 48 hours after challenge.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.4 ml, 25% w/w mixture of the test substance in mineral oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100% HCA
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
Clear erythema in 4 of 10 animals and very faint erythema present in an additional 4 of 10 animals (not considered as positive reaction)
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100% HCA
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Clear erythema in 2 of 10 animals and very faint erythema present in an additional 5 of 10 animals (not considered as positive reaction)
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% HCA
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Very faint erythema in 1 of 5 animals
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% HCA
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Very faint to faint erythema was noted for all test sites during the induction phase. Same observation was noted in positive control sites during the induction phase.

Very faint erythema was noted for five of twenty test sites 24 hours after challenge. Similar irritation persisted at two sites through 48 hours.

Very faint erythema was noted for one of ten naive control sites 24 hours after challenge. Irritation was clear from this site by 48 hours.

Four of ten positive control animals exhibited signs of a sensitization response (faint erythema) 24 hours after challenge. Similar indications persisted at two sites through 48 hours.

Very faint erythema was noted for one naive control site 24 hours after challenge. irritation cleared from the affected site by 48 hours.

Based on these findings the test material is not considered to be a contact sensitizer. The positive response observed in the historical positive control validation study with alpha-hexylcinnamaldehyde technical (HCA) validates the test system used in this study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The in vivo skin sensitisation study for decan-1-ol, conducted according to a protocol similar to OECD Test Guideline 406 and in compliance with GLP, concluded decan-1-ol to be not sensitising to skin.