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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:
16 Dec 1981 - 27 Jan 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. Restriction due to missing details in study report. Missing details did not affect ability to evaluate effect of test substance on skin sensitisation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
During preparation of the original submission, reporting of an existing Buehler-type skin sensitisation test was considered more appropriate than sacrifice of further vertebrate animals in the newly adopted Local Lymph Node Assay.

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
EC Number:
218-679-9
EC Name:
Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
Cas Number:
2215-35-2
Molecular formula:
Too complex
IUPAC Name:
zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino (no additional information available)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data.
- Age at study initiation: no data.
- Weight at study initiation: between 300 and 400 g.
- Housing: the animal were housed and maintained in compliance with the Animal Welfare Act 9 CFR part 3. Five guinea pigs per cage were housed in stainless steel with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Charles River Guinea Pig Formula was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 oF
- Humidity (%): 45 ± 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.

IN-LIFE DATES: From: 16 December 1981 To: 27 January 1982

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: white mineral oil
Concentration / amount:
5% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: white mineral oil
Concentration / amount:
5% w/v
No. of animals per dose:
10 animals per dose
Details on study design:
RANGE FINDING TESTS: Unknown
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 10 days of applications
- Test groups: 1 group of 10 male animals.
- Control group: Not included.
- Site: trunk area
- Frequency of applications: 24 hr exposure followed by 1 day of rest repeated for 10 applications
- Duration: total of 20 days followed by 2 week rest period.
- Concentrations: 5% w/v.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 h
- Test groups: 1 group of 10 male animals.
- Control group: Not included.
- Site: trunk area.
- Concentrations: 5% w/v.
- Evaluation (hr after challenge): 24 hr and 48 hr


Challenge controls:
not included
Positive control substance(s):
not required

Results and discussion

Positive control results:
n/a

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test material does not appear to be a sensitizer in the albino guinea pig.
Executive summary:
In a Modified Buehler Method test, 10 albino Guinea Pigs were treated with 5% w/v test substance, scores of zero in all test animals were obtained in the challenge phase at all time points examined. The test material does not appear to be a sensitizer in the albino guinea pig.

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