Registration Dossier
Registration Dossier
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EC number: 931-700-2 | CAS number: 66455-29-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: J.H. Draize in the F. & D.A. handbook, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (1959)
- Deviations:
- not applicable
- Remarks:
- Test was performed before actual guideline was established
- Principles of method if other than guideline:
- Test was performed before actual guideline was established.
- GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Historical in vivo data available
Test material
- Reference substance name:
- Betaines, C12-14 (even numbered)-alkyldimethyl
- EC Number:
- 931-700-2
- Cas Number:
- 66455-29-6
- Molecular formula:
- C16H33NO2 C18H37NO2
- IUPAC Name:
- Betaines, C12-14 (even numbered)-alkyldimethyl
- Test material form:
- other: aqueous formulation
- Details on test material:
- - Name of test material (as cited in study report): Alkyl dimethyl betaine solutions B/8535 and B/8536
- Physical state: liquid
- Analytical purity: 30 % active ingredient
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300-500 g
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): thermostatically controlled, not further specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % active ingredient
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % active ingredient
- No. of animals per dose:
- 6
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 (1x0.05 ml; 9x0.1 ml)
- Test groups: Test substance in saline
- Site: back, not further specified
- Frequency of applications: every 2 days
- Duration: 0-18 days
- Concentrations: 0.1 % active ingredient
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (0.05 ml)
- Day(s) of challenge: 32
- Test groups: Test substance
- Site: back, not further specified
- Concentrations: 0.1 % active ingredient
- Evaluation (hr after challenge): 4 and 24
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 4
- Group:
- test chemical
- Dose level:
- 0.1 % active ingredient
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- Injection site pink with white centre, 7.0 mm mean diameter, 1.0 mm mean height.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 4.0. Group: test group. Dose level: 0.1 % active ingredient. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: Injection site pink with white centre, 7.0 mm mean diameter, 1.0 mm mean height..
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % active ingredient
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- Injection site pink with white centre, 9.0 mm mean diameter, 1.0 mm mean height; the reaction produced by the final challenge did not appear to be any greater in diameter, height or colour than the reaction produced by any of the previous injections.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % active ingredient. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: Injection site pink with white centre, 9.0 mm mean diameter, 1.0 mm mean height; the reaction produced by the final challenge did not appear to be any greater in diameter, height or colour than the reaction produced by any of the previous injections..
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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