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Toxicological information

Skin sensitisation

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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:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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 group
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 group
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.