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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", by the Staff of the Division of Pharmacology, FDA.
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Mercaptopropansulfonsaures Natrium (MPS)
- Name of test material: 1-Propanesulfonic acid, 3-mercapto-, monosodium salt
- Substance type: organic salt
- Physical state: white, finely crystalline powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 3 kg
- Housing: individual cages
- Diet (e.g. ad libitum): standard diet (Altromin, Lage, Germany) ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ° C ± 2 ° C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or shaved and abraded
Vehicle:
other: powder moistened with water (1:1)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): pure / undiluted

VEHICLE
- none, but moistened with water (1:1)
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
5
Details on study design:
The primary skin irritation was measured with the patch-test method on the shaved and scarified skin of albino rabbits.
0.5 g of test substance were applied to the skin, covered with a cellulose membrane of 2.5 X 2.5 cm (substance administered moistened with water 1: 1).The animals are fixed in the animal holder and the cellulose was attached by using leuco-plast strips. The entire body of the animal was subsequently wrapped with a rubberized cloth for the exposure time of 24 hours, to minimise the possibly of evaporation. After 24 hours the bandage was removed and the local reaction was evaluated by points. The readings are repeated 72 hours after application and the final score is calculated as the average of the 24- and 72-hour reading. After 7 days, a final check of the localization is performed. The reproducibility of the values were defined as 2 treated contacts (shaved and shaved / scarified) and two untreated as a control contact (shaved and shaved / scarified).
Only responses that are markedly different from the control points are to be evaluated as a positive skin reaction.
The resulting mean value is referred to as an index of primary irritation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
In the 24-hour value or later no change could be observed in any animal on the shaved or pre-damaged skin.
Other effects:
no other effects reported

Any other information on results incl. tables

Table 1: Single symptoms of skin irritation

Project-no. 1-3-94-87 Evaluation of skin irritation                        substance:  3-MERCAPTOPROPAN-SULFONSAURES NATRIUM (MPS)*
animal-no. symptom 24-hours, localisation shaved 24 hours localisation scarified 72-hours, localisation shaved 72 hours localisation scarified overall value (mean) 7-days, localisation shaved 7-days localisation scarified
1 eryth. oedema 0 0 0 0 0 0 0
0 0 0 0 0 0
2 eryth. oedema 0 0 0 0 0 0 0
0 0 0 0 0 0
3 eryth. oedema 0 0 0 0 0 0 0
0 0 0 0 0 0
4 eryth. oedema 0 0 0 0 0 0 0
0 0 0 0 0 0
5 eryth. oedema 0 0 0 0 0 0 0
0 0 0 0 0 0
Index of primary skin irritation = 0 
* = 1  : 1 moistened with water. application on the back of the animals

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of high quality (reliability Klimisch 2). The criteria of validity of the test system are fulfilled. The test material did not induce any irritation or corrosion on the intact skin of rabbits. With an index of zero for primary irritation, the product 1-Propanesulfonic acid, 3-mercapto-, monosodium salt (MPS) is considered to be not irritating to the skin (ETAD SUBCOMMITTEE FOR TOXICOLOGY). No concerns are present for contact with the normal skin.
Executive summary:
The skin irritation potential of the test substance was investigated in rabbits (Dickhaus and Heisler, 1987). The test substance was administered to the shaved or shaved and abraded skin for 24 hours and the resulting effects were evaluated. After 24 -hours, or at any later time point no changes of the skin of any animal were observed. Because these observations occurred under the existing strict experimental conditions, the product can be regarded as not irritating to the skin. The contact of the product as a powder with the normal human skin can not be considered as dangerous.