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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 in the report details

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
other: "Appraisal for the Safety of Chemicals in Foods, Drugs and Cosmetics", by the Staff of the Division of Pharmacology, FDA 1959
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-mercaptopropanesulphonate
EC Number:
241-620-3
EC Name:
Sodium 3-mercaptopropanesulphonate
Cas Number:
17636-10-1
Molecular formula:
C3H8O3S2.Na
IUPAC Name:
Sodium 3-mercaptopropanesulphonate
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 powder
- Lot/batch No.: 43 399
- Other: for the experiment, the substance was applied 1 : 1 in water.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SPF-Wistar rats (breeding Winkelmann, Paderborn, Germany)
- Weight at study initiation: ca. 210 g
- Housing: animals were kept in groups of 5 males and 5 females (divided at random) in individual cages
- Diet (e.g. ad libitum): laboratory standard diet (Altromin, Lage)
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ° C ± 2 ° C
- Humidity (%): 50 - 60%
- Photoperiod (hrs dark / hrs light): daily lighting for 12 hours.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
the product was diluted 1 to 1 with water, prior to application
Details on dermal exposure:
For reasons of optimal application of the substance and to allow good skin contact, the animals were shaved completely on the back. The entire trunk was wrapped with two layers of gauze and the undiluted substance was applied to the shaved localization. The treated area was covered with a thin plastic shell and coated with Stülpa. To avoid slipping, the whole body was bonded with adhesive tape, avoiding simultaneously oral ingestion and dehydration of the 1: 1 in water applied substance. The animals were left for 24 hours in this manner. Then the animals were carefully "unpacked" and cleaned with a wet, very warm cloth. The completely wet animals were individually dried by a hairdryer and only after reaching the "optimal cleaned" state, were put in individual farming. After dermal administration, the animals were observed individually housed for 14 days, were they were evaluated using as criteria, the symptoms of poisoning, the clinical behaviour and mortality.
Duration of exposure:
24 h
Doses:
2.5, 5.0 and 7.5 g/kg bw
No. of animals per sex per dose:
5 males and females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were conducted after 24 h, 48 h, after 7 and after 14 days, weighing was done at the beginning and the end of the study
- Necropsy of survivors performed: yes/no: yes (macroscopically examined for pathological changes)
- Other examinations performed: clinical signs, body weights
Statistics:
No data given on statistical methods

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7.5 other: g/kg bw
Based on:
test mat.
Remarks on result:
other: No animals died
Mortality:
No mortalities occurred.
Clinical signs:
The animals behaved after the application a little more quiet than normal, which can be attributed to the bandage. After unpacking and in the further following-up period, the animals behaved physiologically.
Body weight:
In groups 1 to 3 no trial-related differences in the weight gain were observed up to the 14th day post applicationem.
Gross pathology:
In the end section no macroscopic anatomical or pathological findings in the belly, chest and skull were noted.
At the treated spinal sites there were no deviations from normal findings. The dorsal skin appeared subjectively in the highest dose group a little dry or leathery.
Other findings:
no data

Any other information on results incl. tables

Table 1: weekly protocol for clinical observations - group 1

testing period: 7 / 14 days p.a., group:  I = 2,5 g/kg     animal-no.:1-10
Sex:  5 m + 5 f
examination (macroscopically) summary of findings
Appearance/ behaviour physiological
reflexes physiological without special findings
fur and skin turgor physiological, hair was growing evenly
orifices physiological without special findings
faeces (colour and consistency) physiological without special findings
body weight / food and water intake normal body weight gain, normal food and water intake 
acute symptoms none

Table 2: weekly protocol for clinical observations - group 2

testing period: 7 / 14 days p.a., group:  II = 5,0 g/kg     animal-no.:1-10
Sex:  5 m + 5 f
examination (macroscopically) summary of findings
Appearance/ behaviour physiological
reflexes physiological without special findings
fur and skin turgor physiological, hair was growing evenly
orifices physiological without special findings
faeces (colour and consistency) physiological without special findings
body weight / food and water intake normal body weight gain, normal food and water intake 
acute symptoms none

Table 3: weekly protocol for clinical observations - group 3

testing period: 7 / 14 days p.a., group: III = 7,5 g/kg     animal-no.:1-10
Sex:  5 m + 5 f
examination (macroscopically) summary of findings
Appearance/ behaviour physiological
reflexes physiological without special findings
fur and skin turgor physiological, hair was growing evenly
orifices physiological without special findings
faeces (colour and consistency) physiological without special findings
body weight / food and water intake normal body weight gain, normal food and water intake 
acute symptoms none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was performed according to the OECD Guideline 402 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1).The validity criteria of the test system was fulfilled. The test material did not induce any signs of acute dermal toxicity. The test material was considered to be not toxic via the dermal exposure route under the conditions of the test, which is based on the LD50 values derived from this study (LD50 > 7.5 g/kg bw).
Executive summary:

The acute dermal toxicity of 1-Propanesulfonic acid, 3-mercapto-, monosodium salt (MPS) was investigated in rats (Dickhaus and Heisler, 1987). The substance was applied under semi-occlusive conditions to the skin for 24 h. No mortalities occurred and no clinical signs were reported. Therefore the test substance has an LD50 > 7.5 g/kg bw and can be regarded as non-toxic via the dermal exposure route.