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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A GLP guideline guinea pig maximization test was conducted and is considered valid for assessment and it is not necessary to evaluate in additional animals.

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl alcohol
EC Number:
203-470-7
EC Name:
Allyl alcohol
Cas Number:
107-18-6
Molecular formula:
C3H6O
IUPAC Name:
prop-2-en-1-ol
Details on test material:
Lot number: 040420
Purity: 99.9%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Inc.
- Age at study initiation: 5 weeks old
- Weight at study initiation: 331 - 384 grams
- Housing: Until the day before the second induction aluminium cages furnished with a stainless steel mesh flooring (32W x 48D x 33H cm, Tokiwa Kagaku Kikai Co., Ltd.) were used. After the second induction, a hanging type wire netting cages (24W x 36D x 20H cm, Tokiwa Kagaku Kikai Co., Ltd) were used. Cages sterilised by steam were used and replaced at 3, 5, or 7 days interval.
- Diet (e.g. ad libitum): Pellet diet (LABO G Standard, Nihon Nosan Kogyo K.K.) ad libitum
- Water (e.g. ad libitum): Tap water passed through a 5 um filter and sterilised by UV irradiation.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3 - 23.8
- Humidity (%): 49.1 - 78.7
- Air changes (per hr): 6 - 20 changes/hour with fresh air
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
First induction: 1 w/v% solution (test substance solution)
Second induction: 2.5 w/v% solution (test substance solution)
Challenge: Undiluted (Used as supplied by sponsor)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
First induction: 1 w/v% solution (test substance solution)
Second induction: 2.5 w/v% solution (test substance solution)
Challenge: Undiluted (Used as supplied by sponsor)
No. of animals per dose:
20 animals with test substance, 10 animals with negative control (water), 5 animals with DNCB positive control and 5 animals with irritation control for DNCB (olive oil).
Details on study design:
First induction (intradermal injection): An area of 4 x 6 cm on the scapular region was clipped. The next day 0.1 ml of each dosing formulation were injected intradermally into sites 1, 2, 3, 1', 2' and 3'. The formulations are as follows:
- Injection sites 1, 1': Water/FCA
- Injection sites 2, 2': Test substance group (1 w/v% test substance solution); Control group for test substance (water for injection); DNCB group (0.05 w/v% DNCB/olive oil); Control group for DNCB (olive oil).
- Injection sites 3, 3': Test substance group (1 w/v% test substance solution/FCA); Control group for test substance (water/FCA); DNCB group (0.05 w/v% DNCB/FCA); Control group for DNCB (Water/FCA).

Second induction (topical application): Six days after the initial induction, the skin of the induction area was clipped again and 0.5 ml of 10% sodium lauryl sulphate in white petrolatum was spread over the area covering the injection sites. Seven days after the initial induction, 0.2 ml of each dosing formulation (as above) was spread onto a 2 x 4 cm cotton flannel patch and applied to the injection area. This patch was covered with a 5 x 10 cm elastic adhesive bandage back with a 5 x 5 cm polyethylene tape and firmly secured with a 5 x 40 cm elastic adhesive bandage. These patches were removed after 48 hours of their application.

Challenge: The test animals were challenged 21 days after the initial induction. One day before the challenge, the challenge site (4 x 4 cm area) was clipped free of hair. The next day, 0.1 ml of dosing formulation (same as those used in the initial induction) were spread onto a 2 x 2 cm cotton flannel patch and applied to the challenge sites. These patches were covered with an impermeable sheet and secured with a 5 x 70 cm elastic adhesive bandage. These patches were removed 24 hours after the application.
Challenge controls:
10 animals given water only at induction
Positive control substance(s):
yes
Remarks:
DNCB

Results and discussion

Positive control results:
100% sensitisation. All animals displayed intense erythema and swelling.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 w/v% (1st induction); 2.5 w/v% (2nd induction)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No visible changes
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 w/v% (1st induction); 2.5 w/v% (2nd induction). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No visible changes.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 w/v% (1st induction); 2.5 w/v% (2nd induction)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No visible changes
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 w/v% (1st induction); 2.5 w/v% (2nd induction). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No visible changes.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible changes
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No visible changes.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible changes
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No visible changes.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.05 w/v%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
intense erythema and swelling
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05 w/v%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: intense erythema and swelling.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.05 w/v%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
intense erythema and swelling
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.05 w/v%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: intense erythema and swelling.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control for positive control
Dose level:
Olive oil
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible changes
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control for positive control. Dose level: Olive oil . No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No visible changes.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control for positive control
Dose level:
Olive oil
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible changes
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control for positive control. Dose level: Olive oil. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No visible changes.

Any other information on results incl. tables

No test substance treated displayed any skin reactions after challenge. In addition no clinical signs were observed in any test animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, allyl alcohol is not considered to be a skin sensitiser.
Executive summary:

Guinea pigs (20 in a test group, 10 negative controls plus positive controls) used in a maximization test (OECD guideline 406). The positive control material used was DNCB. No allyl alcohol treated animals displayed any skin reaction and no clinical effects were observed.                     

In this study, allyl alcohol did not cause dermal contact sensitisation.