Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 November 1981 - 3 December 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with recognized guideline, well documented report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Magnusson-Kligman Maximization Method.
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
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 deg F

- Humidity (%): 45 ± 5
- Air changes (per hr): no data

- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.


IN-LIFE DATES: From: October, 1981 To: November, 1981

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted
No. of animals per dose:
20 animals per dose
Details on study design:
RANGE FINDING TESTS: Not available.

MAIN STUDY

A. INDUCTION EXPOSURE

- No. of exposures: 2

- Exposure period: 3 weeks

- Test groups: 1 group of 20 male animals

- Control group: Not included

- Site: skin over the shoulders

- Frequency of applications: For induction stage: intradermal injections were made once at 3 pairs of sites simultaneously, 7 days later followed by dermal application of test material. Then the animals were allowed to rest for 2 weeks.

- Duration: total of 3 week time period

- Concentrations: undiluted


B. CHALLENGE EXPOSURE

- No. of exposures: 1

- Day(s) of challenge: 1

- Exposure period: 21 h

- Test groups: 1 group of 20 male animals

- Control group: Not included

- Site: skin over the shoulders

- Concentrations: undiluted.

- Evaluation (hr after challenge): 24 h

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

Study design: in vivo (LLNA)

Concentration:
Undiluted

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no adverse findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no adverse findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no adverse findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no adverse findings.

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 Magnusson-Kligman Guinea Pig maximization test, 20 Dunkin-Harley strain albino Guinea Pigs were treated with undiluted test substance, scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the albino guinea pig.