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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1986-11-25 to 1986-12-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP compliance, samples not moistened

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1981-05-12
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Tin (II)-methane sulphonate (supplier: Riedel-de Haen AG, Seelze)
- Physical state: white, fine-grained powder
- Storage condition of test material: normal room temperature, in darkness

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
- Weight at study initiation: males: 2.1 - 3.2 kg; females: 2.25 - 2.5 kg
- Housing: single caging in battery of cages with paper roll disposal system; size: 40 cm high, 45 cm wide, 50 cm long
- Diet (ad libitum): Ssniff Mü Z^R (Producer: Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen; Type: pellets, 1.0 - 1.5 cm large, 0.5 cm diameter
- Water (ad libitum): aqua fontana
- Acclimation period: 7 days at least

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 2°C
- Relative humidity: 50 - 85%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure/Type of wrap: prior to treatment the back of each animal was clipped (12 x 10 cm) with a small animal clipper. The animals' back of one group was abraded with clean clipper blade so as to penetrate the horny layer of the epidermis, but without causing bleeding. The animals back of the second group was left intact. After treatment the backs of all animals were secured with gauze pads, several wrappings of "Elastoplast" and "Stülpa" for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing: the substance was removed with wet disposable gauze.
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 males / 3 females (scarified skin)
3 males / 3 females (intact skin)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the evaluation of the clinical-toxicological sings (a modified Irving-Screening by Screnning methods in pharmacology, R.A. Turner, 1965) is done individually and depends on the nature of the sings.
Records were made according to the following intervals: 1 h, 2 + 3 h, 6 h, 24/48 h, 3/14 days post administration.
The skin alterations are recorded once daily after termination of the time of exposition for the entire observations period of 14 days. The scoring was done according to the Draize scale.
The body weights are recorded at day 0 (beginning of the experiment) and at day 14 (terminal necropsy) on the survivng animals.
- Necropsy of survivors performed: yes
Immediately after death a complete necropsy is performed on all acute- and late mortalities.
At the end of the 14-day observation period all surviving animals of all groups are sacrificed and gross necropsies are performed.
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: intact skin
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: scarified skin
Mortality:
No mortalities were observed
Clinical signs:
The sample did not induce any clinical-toxicological symptoms
Body weight:
Body weight changes after the observation period showed a normal weight gain
Gross pathology:
Necropsies performed on all animals at termination exhibited no gross pathological findings
Other findings:
No skin alterations were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male/female rats)> 2000 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, tin(II) methanesulphonate is not classified as acute toxic via the dermal route.
According to the EC-Regulation 1272/2008 and subsequent regulations, tin(II) methanesulphonate is not classified as acute toxic via the dermal route.