Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted in compliance with GLP regulations but was well documented and scientifically acceptable. The study was performed according to OECD Guideline 406 (1981) and EEC Guidelines, B.6 (1984).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
Freund's complete adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Procrylat
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: No data
- Purity test date: No data
- Lot/batch No.: No data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No Data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
A 0.5% dilution was utlized in the induction intradermal injections. 10, 30, or 100% dilutions of the test article were utilized in the epicutaneous challenge application.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
A 0.5% dilution was utlized in the induction intradermal injections. 10, 30, or 100% dilutions of the test article were utilized in the epicutaneous challenge application.
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: One intradermal injection on Days 1, 5, and 9
- Test groups: 3 groups of 5 animals
- Control group: 1 group of 5 animals
- Site: Scapular region
- Frequency of applications: Once daily on Days 1, 5, and 9
- Concentrations: 0.5% test article in FCA

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 72 hours
- Test groups: 10, 30, or 100 % diluation of the test article
- Control group: Exposed to a non-irritating solution.
- Site: Flanks
- Concentrations: 10, 30, or 100% dilutions of the test article
- Evaluation (hr after challenge): 24, 48, 72 hours
Challenge controls:
Non-irritating solution.
Positive control substance(s):
no

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None reported.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article presented no evidence of a sensitization potential.
Executive summary:

The dermal sensitization potential of a saline extract of the test article (liquid, lot number not reported) was evaluated in the Freund’s Complete Adjuvant Test using guinea pigs (sex not reported). This study was not performed under GLP guidelines. The study design was based on OECD 406 (1981) and EEC Guidelines, B.6 (1984). This study design is similar to the Guinea Pig Maximization Test. The test article was diluted in vehicle (exact vehicle not listed) prior to administration. Five guinea pigs received intradermal injections on the flanks with 0.1 mL of a 5% dilution of the test article in vehicle with the same volume of Freund’s Complete Adjuvant (FCA) on Days 1, 5, and 9. Five control animals received pretreatment with 0.05 mL of FCA only. On Day 22, all animals received 0.025 mL of 10, 30 or 100% test article as a topical application on one 2 cm2 site per treatment per animal. Skin reactions were read at 24, 48, and 72 hours after application of the test material. No erythema was observed at up to 100% test article on any animals at any time following the challenge treatment. Based on the results of this study, the test article presented no evidence of a sensitization potential.