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EC number: 203-490-6 | CAS number: 107-43-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 NOV 1988 to 16 DEC 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not required as a 1989 guinea pig study with the test substance was availableto fill the requirement.
Test material
- Reference substance name:
- Betaine
- EC Number:
- 203-490-6
- EC Name:
- Betaine
- Cas Number:
- 107-43-7
- Molecular formula:
- C5H11NO2
- IUPAC Name:
- (trimethylammonio)acetate
- Details on test material:
- Betaine, >97% purity (product name Betafin AP)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Darley Oaks, Burton-om-Trent, Staffordshire, UK.
- Age at study initiation: -
- Weight at study initiation: control mean 434g S.D. 27.7, test 432g S.D. 37.5
- Housing: groups of ten, stainless steel cages (85x57x25cm) with mesh floors
- Diet (e.g. ad libitum): FDI, SQC Guinea Pig Diet, (Special diets Services, Witham, Essex, UK) with additional C-vitamin.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 45-68
- Air changes (per hr):-
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
From: - To: 16 DEC 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Freund's complete adjuvant
- Concentration / amount:
- 50% betaine solution for induction and for challenge test 50% and 20% v/v of betaine and 40% mixture of 20/20 of betaine and Freund's adjuvant.
Range test: 1. 5. 10. 20 and 50% from which 20% was chosen as the minimum as it was the lowest dose to cause minimum localised response.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freund's complete adjuvant
- Concentration / amount:
- 50% betaine solution for induction and for challenge test 50% and 20% v/v of betaine and 40% mixture of 20/20 of betaine and Freund's adjuvant.
Range test: 1. 5. 10. 20 and 50% from which 20% was chosen as the minimum as it was the lowest dose to cause minimum localised response.
- No. of animals per dose:
- 10 female Dunkin-Hartley albino guinea pigs.
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: Seven days, observation 24 / 48 hours
- Test groups: 2 animals
- Control group: 2 animals
- Site: shoulder region
- Frequency of applications: 7 days
- Duration: two weeks
- Concentrations: 50, 20, 10, 5 and 1% (w/v) aqueous concentrations.
B. CHALLENGE EXPOSURE
- No. of exposures: three pairs, 0.1ml
- Day(s) of challenge: 7, 14
- Exposure period:
- Test groups: 20
- Control group: 20
- Site: shoulder region and back (left / right flank)
- Concentrations: betaine 50%, 20% and 40% (20% betaine, 20% freund's adjuvant)
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- 1) 50% Freund's Complete Adjuvant emulsified in distilled water
2) distilled water
3)50% Freund's Complete Adjuvant emulsified in distilled water - Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not measured
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not measured
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this OECD TG 406 study betaine is classified as a non sensitising substance (grade 1 sensitiser on the Magnusson and Kligman scale, having sensitisation rate of 0%). Range finding tests indicated that the lowest dose causing any reaction is 20% (v/v) so for the actual challenge test 50% (v/v) was chosen for induction. Neither of these caused any kind of sensitisation.
- Executive summary:
Based on this OECD TG 406 study betaine is classified as a non sensitising substance (grade 1 sensitiser on the Magnusson and Kligman scale, having sensitisation rate of 0%). Range finding tests indicated that the lowest dose causing any reaction is 20% (v/v) so for the actual challenge test 50% (v/v) was chosen for induction. Neither of these caused any kind of sensitisation.
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