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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
27th September 2000 - 27th September 2001
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Study conducted in compliance with agreed protocols, with minor deviations from standard test guidelines and minor methodological deficiencies, which affect the quality of the relevant results. Reduced reliability as stusy is being used for read across purposes.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
according to guideline
EU Method B.3 (Acute Toxicity (Dermal))
Principles of method if other than guideline:
Study Plan amendments as listed by study director:
A second group of 5 male and 5 female animals was treated at 1000 mg/kg and corn oil was used for the dilution. The test item preparation was adapted. The name of the sponsor was changed. Correction in the test item formulation.
The result of the study is inconclusive as all animals in the 2000 mg/kg bw group were sacrificed on humane grounds on day 8 of the study period due to severe skin irritation.
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Di-n-butyltin bis (2-ethylhexylthioglycolate)
Di-n-butyltin bis (2-ethylhexylthioglycolate)
Details on test material:
- Name of test material (as cited in study report): Mark 17 M
- Substance type: Organotin compound
- Physical state: liquid
- Analytical purity: 61.8 %
- Main component: Di-n-butyltin bis (2-ethylhexylthioglycolate)
- Impurities (identity and concentrations): 25.3 % Mono-n-butyltin tris (2-ethylhexylthioglycolate)and 12.9 % epoxidised soyabean oil.
- Isomers composition: N/A
- Purity test date: NDA
- Expiration date of the lot/batch: 30th April 2002
- Stability storage test conditions: stable
- Storage condition of test material: In the original container at room temperature (20 ± 3 ºC), away from direct sunlight.

Test animals

Details on test animals or test system and environmental conditions:
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414, Füllingsdorf, Switzerland
- Age at study initiation: Males = 9 weeks. Females = 10 - 11 weeks.
- Weight at study initiation: Males = 242.2 - 265.3 g. Females = 181.5 - 218.0 g.
- Fasting period before study: NDA
- Housing: Makrolon type 4 cages with softwood bedding in groups of 5 rats during acclimation. Makrolon 3 type cages individually during testing and observation.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week under lab conditions

- Temperature (°C): 21 - 23.5 ºC
- Humidity (%): 33- 56 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- Music: Played during the light hours.

IN-LIFE DATES 1000 mg/kg : From: 27th September 2000 To: 11th October 2000
IN-LIFE DATES 2000 mg/kg : From: 6th February 2001 To: 27th February 2001

Administration / exposure

Type of coverage:
corn oil
Details on dermal exposure:
The test item was applied undiluted for the dose of 2000 mg/kg or placed into a glass beaker on a tared Mettler PM 460 balance for the dose of 1000 mg/kg and corn oil was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test item in the vehicle was maintained during treatment.
The preparation was made shortly before the dermal application.
Dose levels were in terms of material as supplied by the sponsor.

- Area of exposure: see below
- % coverage: 10 % of body surface
- Type of wrap if used: Semi occlusive dressing wrapped around the abdomen and fixed with elastic adhesive bandage

- Washing (if done): Application area flushed with luke warm water and dried with paper towels.
- Time after start of exposure: 24 hours

- Amount(s) applied (volume or weight with unit): 1000 and 2000 mg/l
- Concentration (if solution): N/A
- Constant volume or concentration used: constant volume

- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
Duration of exposure:
24 hours
1000 and 2000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 1, 8 and 15 for surviving animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: None
No statistical analysis used.

Results and discussion

Preliminary study:
not applicable
Effect levels
Dose descriptor:
Effect level:
> 1 000 mg/kg bw
No animals died at 1000 mg/kg level.
At 2000 mg/kg, all animals were killed on day 8 due to ethical reasons. Animals were showing signs of severe irritation.
Clinical signs:
other: No clinical signs were noted during the observation period. Local signs: Well defined erythema was observed in all 2000 mg/kg dosed animals after removing of dressing. Moderate to severe erythema was observed in all animals from days 3 -5 and on day 6, se
Gross pathology:
No macroscopic findings observed at Necropsy.
Other findings:
None specified.

Applicant's summary and conclusion

Interpretation of results:
other: Inconclusive. Test stopped early for ethical reasons.
Criteria used for interpretation of results: EU
The median lethal does of Mark 17 M after a single dermal administration to rats of both sexes, observed over a period of 15 days is:
LD50 (rat): > 1000 mg/kg body weight.

All animals treated with 2000 mg/kg were killed for ethical reasons on day 8 due to severe signs of irritation observed. The results (LD50) for these test animals are classified as inconclusive.
Executive summary:

In an acute dermal toxicity study according to OECD test guideline 402, groups of 9 week old male and 10 - 11 week old female rats were dermally exposed to Mark 17 M for 24 hours at doses of 1000 and 2000 mg/kg bw. Animals dosed with 1000 mg/kg bw were then observed for 14 days. All animals treated with 2000 mg/kg were killed for ethical reasons on day 8 due to severe signs of irritation observed. The LD50 result (see below) for these test animals are classified as inconclusive.

LD50 (rat): > 1000 mg/kg body weight.

Read across from DBT-2EHMA (CAS: 10584-98-2)