Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1995
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RA 3643
- Physical state: white powder
- Lot/batch No.: 51/95
- Storage condition of test material: ambient and in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: SPF-bred albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 2-3 weeks (ordered)
- Housing: in a mobile battery containing 4 cages; one cage per group of at most 10 animals
- Diet (e.g. ad libitum): pelleted, natural ingredient diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 58-85%
- Air changes (per hr): about 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark cycle

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
petrolatum
Concentration / amount:
0.1 ml for the intradermal injection
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
0.1 ml for the intradermal injection
No. of animals per dose:
Preliminary testr: two sets of 3 animals
Main study: test group of 5 males and 5 females; control group of 3males and 3 females

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
30% dilution of test item
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% dilution of test item. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no dermal reaction.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
the test substance RA 3643 is considered not to be a sensitizer
Executive summary:

The test substance RA 3643 was examined for possible sensitizing properties by a maximization test in guinea pigs using 10 test animals and 6 controls.

The test comprised:

TEST ANIMALS

- induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 diluted with isotonic saline, a 3% dilution of RA 3643 in maize oil, and a 3% dilution of RA 3643 in vaseline (test site pretreated with sodium lauryl sulfate),

- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,

CONTROLS

- induction treatment by intradermal injections of FCA 1:1 diluted with isotonic saline, maize oil, and FCA/saline 1:1 diluited with maize oil, followed one week later by topical application of patches loaded with vaseline (test sites pretreated with sodium lauryl sulfate), and

- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,

None of the test animals reacted positively. Therefore, the test substance RA 3643 is considered not to be a sensitizer. Since clear and unequivocal results were obtained in this study, no need for further examination in an additional batch of test and control animals is required.