Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 April to 19 May 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been QA audited and has been conducted in the spirit of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
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): Bisphenol-M
- Substance type: Monomer
- Physical state: Fine white crystals
- Analytical purity: 99.5%
- Lot/batch No.: 5426

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Laboratory supplier
- Weight at study initiation: 305 to 392 g
- Housing: Guinea-pigs were housed in high density polypropylene cages measuring 56 x 38 x 18 cm, with stainless steel grid floors and tops.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 55
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Freunds complete adjuvant for anterior sites and distilled water for middle and posterior sites.
Concentration / amount:
Intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled water and the test site was covered by an occlusive dressing for 48 hours.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Freunds complete adjuvant for anterior sites and distilled water for middle and posterior sites.
Concentration / amount:
Intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled water and the test site was covered by an occlusive dressing for 48 hours.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 hours
- Test groups: 1
- Control group:
- Site: Shaven dorsa
- Frequency of applications: guinea-pigs were subject to intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled water and the test site was covered by an occlusive dressing for 48 hours.
- Duration:
- Concentrations:guinea-pigs were subject to intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled wate.

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Day 8
- Exposure period: 48 hours
- Test groups:
- Control group: Yes
- Site: right and left flanks
- Concentrations:distilled water to the left flank and 50% w/v Bisphenol-M in -distilled water to the right flank.
- Evaluation (hr after challenge): 24 and 48 hours

OTHER:
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Evidence of sensitisation of each challenge concentration: Slight confluiding or moderate spotty erythema was found in 1 animal of the test group and in 3 animals from the control group.

Other observations:

The intradermal application of the preparations used in the first phase of the induction caused moderate erythema at all tested areas where FCA was used. After injection of 10 % substance in distilled water or only distilled
water no skin changes were observed.

After the occlusive topical application of distilled water in the animals of the control group and in the animals of the test group after the 50 % substance treatment in distilled water no skin reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU