Registration Dossier
Registration Dossier
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EC number: 428-970-4 | CAS number: 13595-25-0
Skin sensitisation
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:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Bisphenol-M
- IUPAC Name:
- Bisphenol-M
- 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
Constituent 1
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 chemical
- 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 chemical
- 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
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