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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline study, non-GLP study but conducted according to valid scientific standards still acceptable compared to nowadays existing guidelines. Study sufficiently reported and documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
10 i.c. injections within 14 days of first induction phase; 2 challenge treatments
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study data were obtained in studies performed before any in vitro sensitization tests had been validated and accepted for regulatory purposes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hostapur SAS 60
- Physical state: pasty
- Analytical purity: 60%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 60% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: 60%
- Lot/batch No.: no data
- Expiration date of the lot/batch: 1976
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: no data
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in house breeding
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
No. of animals per dose:
6 animals for irritation screen
15 animals for main study
Details on study design:
RANGE FINDING TESTS: Yes, irritation screen with 6 animals


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 intradermal injections
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Concentrations: 0.0 mL of a solution of 500 mg Hostapur SAS in 10 mL Freund`s complete adjuvans for intradermal induction



B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Concentrations: 5% in water
- Evaluation (hr after challenge): 24 and 48 hours after each challenge treatment

Challenge controls:
Yes
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:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing
Executive summary:

Sec-alkane sulfonate-sodium salts SAS (60%) was examined for its capacity to cause contact allergy by the maximization test according to Magnusson and Kligman with guinea pigs. Based on a screening study using groups of 6 male guinea pigs the highest non-irritating concentration of sec-alkane sulfonate-sodium salts SAS (60%) was established to be 5% in water. In the main study 15 male guinea pigs were used. Induction exposure included 10 intracutaneous injections of 0.05 mL of a solution of 500 mg sec-alkane sulfonate-sodium salts SAS (60%) in 10 mL of Freund`s complete adjuvant. Challenge was made 14 days after the last injection using 0.1 mL of sec-alkane sulfonate-sodium salts SAS (60%) at 5% test concentration. Readings performed 24 and 48 hours after the challenge treatment revealed no signs of skin reactions (sensitization incidence = 0%). Additionally, also a second challenge treatment using the same test conditions like in the first challenge revealed no signs of skin reactions (sensitization incidence = 0%). Thus it was concluded that sec-alkane sulfonate-sodium salts SAS is not a skin sensitizer.