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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:
weight of evidence
Study period:
1999-09-09 to 1999-10-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed before the LLNA method was the first choice method for this endpoint

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Axenohl
- Physical state: clear liquid
- Expiration date of the batch: September 2000
- Stability under test conditions: Test substance is expected to be stable for the duration of testing
- Storage condition of test material: store at room temperature
No further information on test material was stated

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson´s Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: young adult
- Weight at study initiation: males 242-316g, females 251-340g
- Housing: group housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Guinea Pig Chow # 5025
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by automatic water dispensing system
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled
Concentration / amount:
75% w/w solution of the test substance in distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled
Concentration / amount:
75% w/w solution of the test substance in distilled water
No. of animals per dose:
- Number of animals: 34
- Number of Groups: 3
- Number of animals per group: Preliminary Irritation Group: 4/ Test Group: 20/ Test Naive Control Group: 10
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: three weeks
- Test groups: 20 animals
- Control group: 10 animals
- Site: left site of the dorsal area
- Frequency of applications: once a week for three weeks
- Duration: 6 hours
- Concentrations: 0.4ml of 75% w/w solution of test substance in distilled water

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27 days after the first induction dose
- Exposure period: 2 days
- Test groups: 20 animals
- Control group: 10 animals
- Site: right side of the dorsal area
- Concentrations: 0.4ml of 50% w/w solution of the test substance in distilled water
- Evaluation (hr after challenge): 24hr and 48 hr
Challenge controls:
naive control: 50 % w/w test solution
historical positive control: 0.04% DNCB in avetone
historical positive naive control: 0.04% DNCB in acetone
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-Dinitrobenzene (DNCB)

Results and discussion

Positive control results:
Induction Phase:
Very faint to severe erythema (0.5-3) was noted
Challenge Phase:
Eight of ten positive control animals exhibited signs of a sensitization response (faint to moderate rythema [1-2] 24 and /or 48h after challenge

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 % w/w
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
very faint erythema (0.5)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 % w/w
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
very faint erythema (0.5)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
Reading:
1st reading
Hours after challenge:
24
Group:
other: naive control group
Dose level:
50 % w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
very faint erythema (0.5)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:
Reading:
2nd reading
Hours after challenge:
48
Group:
other: naive control group
Dose level:
50 % w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
very faint erythema (0.5)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group:
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.04% DNCB in acetone
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
faint to moderate erythema (1-2)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.04% DNCB in acetone. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema (1-2).
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.04% DNCB in acetone
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
faint to moderate erythema (1-2)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.04% DNCB in acetone. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema (1-2).
Reading:
1st reading
Hours after challenge:
24
Group:
other: positive naive control group
Dose level:
0.04% DNCB in acetone
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
very faint erythema (0.5)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:
Reading:
2nd reading
Hours after challenge:
48
Group:
other: positive naive control group
Dose level:
0.04% DNCB in acetone
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no irritation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on these findings and on the evaluation system used, Axenohl is not considered to be a contact sensitizer.