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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-study with minor deficiencies i.e. concerning report details

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
only 15 test animals, open epicutaneous application, 3 times 5 daily applications, same dose in induction and challenge
Qualifier:
according to
Guideline:
other: Empfehlung der Deutschen Gesellschaft für Fettwissenschaften e. V. fur die Prüfung von KörperpflegemitteIn auf gesundheitliche Unbedenklichkeit
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Mercaptopropansulfonsaures Natrium (MPS)
- CAS-Name of test material: 1-Propanesulfonic acid, 3-mercapto-, monosodium salt
- Substance type: organic salt
- Physical state: white powder
- Lot/batch No.: 43 399
- Other: for the experiment, the substance was applied 1 : 1 in water.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS: Hartley outbred guinea pigs (15 test animals and 15 control animals)
- Weight at study initiation: 428 g
- Housing: in groups of 5 animals
- Diet (e.g. ad libitum): standard diet
- Water (e.g. ad libitum): water with 0.25% ascorbic acid ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ° C ± 2 ° C
- Humidity (%): 50 - 60%
- Photoperiod (hrs dark / hrs light): daily lighting for 12 hours

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
0.5 g of pure test substance moistened 1:1 with water
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
0.5 g of pure test substance moistened 1:1 with water
No. of animals per dose:
15
Details on study design:
According to the recommendations, a concentration should be chosen, which is in the suberythemal area. Then 0.5 g of test substance moistened with water (about 1:1) was applied to the shaved skin of guinea pigs and rubbed in gently. The treatment was repeated over 3 weeks at each of 5 consecutive days (3 times 5 days). Before each application, the skin reaction were assessed and evaluated according to the rating key to Draize. In addition, the skin reactions were evaluated 24 and 48 hours after the 5th application. 14 days after the last application on the contralateral side 2 treatments were made at intervals of 24 hours. The assessment of skin reactions following the last treatment was at 24, 48 and 72 hours.
Challenge controls:
No skin reactions were noted in the control group.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
0.5 g test material (moistened with water; 1:1)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 0.5 g test material (moistened with water; 1:1). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
2nd reading
Group:
test group
Dose level:
05. g test material (moistened with water; 1:1)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: 05. g test material (moistened with water; 1:1). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
rechallenge
Group:
test group
Dose level:
0.5 g test material (moistened with water; 1:1)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. Group: test group. Dose level: 0.5 g test material (moistened with water; 1:1). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.

Any other information on results incl. tables

During the first 3 weeks of treatment including the inductionphase, no erythema or oedema was observed. In the control animals no skin irritation was observed.
Body weights were observed for 5 weeks. No evidence of intolerance was found between the test animals compared to those of the controls. The clinical picture of the animals was assessed weekly. No test-specific changes were observed. The retesting showed no evidence of sensitizing properties.

Table 1: Evaluation of skin sensitisation - week 1

Evaluation of skin sensitisation: test group, week one, substance 1-Propanesulfonic acid, 3-mercapto-, monosodium salt, project-no. 2-5-106-87
Animal-no. symptom day 1 day 2 day 3 day 4 day 5 day 6 day 7
1 erythema/oedema 0 0 0 0 0 0 0
2 erythema/oedema 0 0 0 0 0 0 0
3 erythema/oedema 0 0 0 0 0 0 0
4 erythema/oedema 0 0 0 0 0 0 0
5 erythema/oedema 0 0 0 0 0 0 0
6 erythema/oedema 0 0 0 0 0 0 0
7 erythema/oedema 0 0 0 0 0 0 0
8 erythema/oedema 0 0 0 0 0 0 0
9 erythema/oedema 0 0 0 0 0 0 0
10 erythema/oedema 0 0 0 0 0 0 0
11 erythema/oedema 0 0 0 0 0 0 0
12 erythema/oedema 0 0 0 0 0 0 0
13 erythema/oedema 0 0 0 0 0 0 0
14 erythema/oedema 0 0 0 0 0 0 0
15 erythema/oedema 0 0 0 0 0 0 0

Table 2: Evaluation of skin sensitisation - week 2

Evaluation of skin sensitisation: test group, week two, substance 1-Propanesulfonic acid, 3-mercapto-, monosodium salt, project-no. 2-5-106-87
Animal-no. symptom day 1 day 2 day 3 day 4 day 5 day 6 day 7
1 erythema/oedema 0 0 0 0 0 0 0
2 erythema/oedema 0 0 0 0 0 0 0
3 erythema/oedema 0 0 0 0 0 0 0
4 erythema/oedema 0 0 0 0 0 0 0
5 erythema/oedema 0 0 0 0 0 0 0
6 erythema/oedema 0 0 0 0 0 0 0
7 erythema/oedema 0 0 0 0 0 0 0
8 erythema/oedema 0 0 0 0 0 0 0
9 erythema/oedema 0 0 0 0 0 0 0
10 erythema/oedema 0 0 0 0 0 0 0
11 erythema/oedema 0 0 0 0 0 0 0
12 erythema/oedema 0 0 0 0 0 0 0
13 erythema/oedema 0 0 0 0 0 0 0
14 erythema/oedema 0 0 0 0 0 0 0
15 erythema/oedema 0 0 0 0 0 0 0

Table 3: Evaluation of skin sensitisation - week 3

Evaluation of skin sensitisation: test group, week tree, substance 1-Propanesulfonic acid, 3-mercapto-, monosodium salt, project-no. 2-5-106-87
Animal-no. symptom day 1 day 2 day 3 day 4 day 5 day 6 day 7
1 erythema/oedema 0 0 0 0 0 0 0
2 erythema/oedema 0 0 0 0 0 0 0
3 erythema/oedema 0 0 0 0 0 0 0
4 erythema/oedema 0 0 0 0 0 0 0
5 erythema/oedema 0 0 0 0 0 0 0
6 erythema/oedema 0 0 0 0 0 0 0
7 erythema/oedema 0 0 0 0 0 0 0
8 erythema/oedema 0 0 0 0 0 0 0
9 erythema/oedema 0 0 0 0 0 0 0
10 erythema/oedema 0 0 0 0 0 0 0
11 erythema/oedema 0 0 0 0 0 0 0
12 erythema/oedema 0 0 0 0 0 0 0
13 erythema/oedema 0 0 0 0 0 0 0
14 erythema/oedema 0 0 0 0 0 0 0
15 erythema/oedema 0 0 0 0 0 0 0

Table 4: Evaluation of skin sensitisation after 24h, 48h and 72 hours

skin reactions after 14 days rest and two application in the test group 
substance: 1-Propanesulfonic acid, 3-mercapto-, monosodium salt, project-no. 2-5-106-87
Animal-no. Symptom 24 hours 48 hours 72 hours
1 erythema 0 0 0
oedema 0 0 0
2 erythema 0 0 0
oedema 0 0 0
3 erythema 0 0 0
oedema 0 0 0
4 erythema 0 0 0
oedema 0 0 0
5 erythema 0 0 0
oedema 0 0 0
6 erythema 0 0 0
oedema 0 0 0
7 erythema 0 0 0
oedema 0 0 0
8 erythema 0 0 0
oedema 0 0 0
9 erythema 0 0 0
oedema 0 0 0
10 erythema 0 0 0
oedema 0 0 0
11 erythema 0 0 0
oedema 0 0 0
12 erythema 0 0 0
oedema 0 0 0
13 erythema 0 0 0
oedema 0 0 0
14 erythema 0 0 0
oedema 0 0 0
15 erythema 0 0 0
oedema 0 0 0

Table 5: Evaluation of skin sensitisation after retesting - reading after 24 h, 48 h and 72 hours

Individual allergic reactions in the sensitisation test with 1-Propanesulfonic acid, 3-mercapto-, monosodium salt after induction
project-no. 2-5-106-87
Animal-no. retesting retesting retesting
  24 hours 48 hours 72 hours
1 0 0 0
2 0 0 0
3 0 0 0
4 0 0 0
5 0 0 0
6 0 0 0
7 0 0 0
8 0 0 0
9 0 0 0
10 0 0 0
11 0 0 0
12 0 0 0
13 0 0 0
14 0 0 0
15 0 0 0
in total 0 0 0
classification:   0 = negative

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The GLP-study was performed according to the OECD Guideline 406, buehler test with deviations (only 15 test animals, open epicutaneous application, 3 times 5 daily applications, same dose in induction and challenge, no positive control substance) and is considered to be reliable with restrictions (reliability Klimisch 2). The test material did not induce any response during the 3 weeks of treatment and during the retesting on the skin of guinea pigs. The test material was considered to be not sensitising under the conditions of the test since no evidence of sensitizing or allergenic properties was found.
Executive summary:

The test item was tested for its sensitising potential according to OECD Guideline 406 in guinea pigs (Dickhaus and Heisler, 1987). The procedure used was based on that of Buehler. The test included three phases: induction phase, when test material is applied to hair free skin of test animals openly on the epidermis for a total of fifteen applications; two-week rest period during which an immune response may develop and challenge phase during which the immune system if sensitized react hypersensitive (2 applications in a 24 hour rhythm). 15 test animals and 15 control animals were used in the study. 0.5 g of test material moistened with sterile water was used in the induction phase and in the challenge phase. Treated skin sites were scored according scale as described in the Buehler test method. 24, 48 and 72-hour readings were performed after the challenge applications. No skin reactions were noted at the treated sites of the test or control group animals at the 24 or 48 -hour reading . Therefore the substance is not considered to be a skin sensitizer.