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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1st to 15th September 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. No purity reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Principles of method if other than guideline:
- Only 2 doses used and the doses were high.
- Test was terminated after 7 days to avoid unnecessary suffering, meaning a specific LD50 could not be calculated.
- Occlusive dressing was used, preferred is semi-occlusive.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
EC Number:
239-594-3
EC Name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Cas Number:
15546-11-9
Molecular formula:
C18H28O8Sn
IUPAC Name:
methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Details on test material:
- Name of test material (as cited in study report): TK 11.637
- Physical state: liquid
- Lot/batch No.: 250-252

Test animals

Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Raised on site
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: ~191 - 222 g
- Housing: During the treatment and observation periods the animals were housed individually in Macrolon cages; type 2
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG Ltd., Gossau; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12 hours light per day

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: ~60 square centimetres
- Type of wrap if used: covered with an occlusive dressing, which was fastened around the trunk with an adhesive elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed, the skin was cleaned with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2500 & 5000 mg/kg/bw

Duration of exposure:
24 hours
Doses:
2500 & 5000 mg/kg/bw
No. of animals per sex per dose:
5 males & 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days, experiment was terminated to avoid unnecessary suffering at 2500 mg/kg dose
- Frequency of observations and weighing: Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals treated with 2500 mg/kg were dead 7 days after treatment, when the experiment was terminated to avoid unnecessary suffering. However the heavy weight loss of 20% indicates, that deaths during the second week after treatment might well have been possible.
In the 5000 mg/kg dose group, 3 males died on day 5 and 2 females died 1 on day 3 and 1 on day 5).
Clinical signs:
The systemic signs exhibited by the rats were those of general distress such as sedation, dyspnoea, ruffled fur, ventral and curved body position and diarrhoea. On the application site erythema developed within the first 24 hours; on the second day necrosis was also seen. After 6 days, the first open wounds became visible at the border of the necrotic area and a few days later the whole skin of the back was sloughing off leaving the muscles exposed to the air.
Body weight:
There was a marked decrease of the body-weight during the first week after the administration of the test material.
Gross pathology:
No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test material seems to be about 5000 mg/kg after one week of observation.
Executive summary:

The acute dermal LD50 of the test material seems to be about 5000 mg/kg after one week of observation.

The whole treated area of the skin became necrotic and started to slough off seven days after the application of the test material. To avoid unnecessary suffering the experiment was therefore terminated after one instead of two weeks.

After treatment a heavy weight loss was also observed.