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Registration Dossier
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EC number: 287-024-7 | CAS number: 85408-62-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This Modified Buehler Test was conducted in accordance with EC Guideline B.6, OECD Guideline 406, and GLP procedures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Modified Buehler Test in accordance with EC Guideline B6.
- GLP compliance:
- yes
- Remarks:
- Conducted in accordance with GLP
- Type of study:
- Buehler test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- SCI
- Name of test material (as cited in study report): Hostapon SCID
- Physical state: Yellow - White flakes
- Analytical purity: 68.7%
- Impurities (identity and concentrations): Stearic Acid (19%, Coconut Fatty Acid (7%), Sodium Isethionate (4%)
- Composition of test material, percentage of components: Sodium Cocoyl Isethionate (66%)
- Isomers composition: Not applicable.
- Purity test date: July 1993.
- Lot/batch No.: Batch 1 July 1993
- Expiration date of the lot/batch: No data.
- Radiochemical purity (if radiolabelling): Not applicable.
- Specific activity (if radiolabelling): Not applicable.
- Locations of the label (if radiolabelling): Not applicable.
- Expiration date of radiochemical substance (if radiolabelling): Not applicable.
- Stability under test conditions: No data.
- Storage condition of test material: No data.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: No data.
- Age at study initiation: No data
- Weight at study initiation: 316 to 403 g
- Housing: Housed singly in wire mesh suspension cages
- Diet (e.g. ad libitum): No data on diet, but food provided ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- 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:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
- No. of animals per dose:
- 20 (test group), 10 (control group).
- Details on study design:
- RANGE FINDING TESTS:
Primary irritation:
The test material was applied to six animals to determine the concentration appropriate for use during the primary challenge. The materials was tested as 25%, 50% and 100% w/v in distilled water. A concentration of 100% w/v in distilled water was determined for use in induction and primary challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (once per week over 3 week period).
- Exposure period: 6 Hours.
- Test groups: 20 test animals (10 male, 10 female) at 100%
- Control group: 10 control animals (5 male, 5 female) distilled water only.
- Site: Upper, left quadrant of back (clipped)
- Frequency of applications: Once per week, over 3 week period.
- Duration: 6 hours per exposure
- Concentrations: 0.5g of test material as 100% w/v in distilled water.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 day
- Exposure period: 6 hours
- Test groups: 20 test animals (10 male, 10 female) at 100%
- Control group: 10 control animals (5 male, 5 female) distilled water only.
- Site: Lower, right flank (clipped)
- Concentrations: 0.5g of test material as 100% w/v in distilled water.
- Evaluation (hr after challenge): 24 and 48 hours after application. - Challenge controls:
- A challenge patch moistened with 0.5g of the test material as 100% w/v was applied to each control animal, occluded for 6 hours and removed.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- 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: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No reactions were observed during the challenge phase indicating that sensitisation had not been induced.
- Executive summary:
No reactions were observed during the challenge phase indicating that sensitisation had not been induced.
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