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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
17 May 1979 to 20 June 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was applied once dermally to the prepared sites under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material. Dermal reactions were scored at 24 hours, days 3, 7 & 14 by the Draize scoring system. The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane
EC Number:
245-912-1
EC Name:
Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane
Cas Number:
23850-94-4
Molecular formula:
C28H54O6Sn
IUPAC Name:
butyltris[(2-ethyl-1-oxohexyl)oxy]stannane
Test material form:
liquid
Details on test material:
- Appearance: clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 2.2 - 2.8 kg
- Housing: The animals were housed 2/cage in suspended wire mesh cages (30 x 18 x 18 ").
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 21 °C

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Immediately prior to dosing, the fur was clipped from the abdomen of the animals. The clipped area was 200 cm².
- % coverage: 10% of the body surface
- Type of wrap if used: The test material was applied once dermally to the prepared sites under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded.
- The exposure site was wiped, but not washed, to remove excess material.

TEST MATERIAL
- Amount(s) applied: 2.0, 4.0, 8.0 and 16.0 g/kg.
Duration of exposure:
24 hours
Doses:
2.0, 4.0, 8.0 and 16.0 g/kg.
No. of animals per sex per dose:
- 2.0 and 4.0 g/kg: 2 animals per sex
- 8.0 g/kg: 3 males and 1 female
- 16.0 g/kg: 1 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Dermal reactions were scored at 24 hours and on days 3, 7 and 14 according to the Draize scoring system.
- The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality.
- Body weights were recorded pre-test and in the survivors at 14 days.
- The rabbits were not examined for gross pathology.
Statistics:
The LD50, if possible, was calculated according to the method of Litchfield & Wilcoxon.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the testing.
Clinical signs:
other: Isolated instances of lethargy, ptosis, few faeces in pan, and yellow nasal discharge were sporadically noted in 3 animals. Eight out of thirteen animals appeared normal at all times. Lethargy was noted in two animals on day 0, but had cleared by day 1 an
Gross pathology:
Not performed.

Any other information on results incl. tables

Table 1: Individual Bodyweights

Dose level (g/kg)

Animal No. and sex

Bodyweight (kg)

Day 0

Day 14

2.0

1-F

2.7

2.9

2-F

2.5

2.7

3-M

2.8

2.9

4-M

2.8

3.0

4.0

5-M

2.2

2.5

6-M

2.4

2.5

7-F

2.5

2.5

8-F

2.4

2.5

8.0

9-M

2.7

2.6

10-M

2.8

2.8

11-F

2.5

2.4

12-M

2.5

2.7

16.0

13-M

2.6

2.5

 

Table 2: Dermal Scores

Dose level (g/kg)

Animal No. and sex

Dermal Scores

Day 0

Day 3

Day 7

Day 14

E

O

E

O

E

O

E

O

2.0

1-F

2

2

2

2

1f

0

0

0

2-F

2

1

2

1

1f

1

0

0

3-M

1

1

1

1

1f

0

1

0

4-M

1

1

2

2

1

1

1

0

4.0

5-M

2

2

2

2

1f

2

0f

0

6-M

1

2

2

2

1f

2

0f

0

7-F

2

2

2

2

1f

1

1f

0

8-F

3

1

3

2

2f

1

1f

0

8.0

9-M

2

2

3

3

4f

2

4fe

2

10-M

3

2

3

2

2

2

4fe

2

11-F

2

2

2

3

3

2

4fe

2

12-M

3

2

2

2

2

2

4fe

2

16.0

13-M

2

2

2

2

3f

2

4fe

2

E = erythema

O = oedema

e = slight eschar

f = skin flaking

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU Criteria
Conclusions:
Under the conditions of this study the acute dermal LD50 of the test material was determined to be greater than 8000 mg/kg.
Executive summary:

The acute dermal toxicity of the test material was determined in a study using New Zealand White rabbits.

During the study, animals were treated with a dose of 2.0, 4.0, 8.0 or 16.0 g/kg of test material under an occlusive patch for 24 hours. The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pre-test and in the survivors on day 14. Dermal reactions were scored at 24 hours and on days 3, 7 and 14 according to the Draize scoring system.

Under the conditions of the study all animals survived. Isolated instances of lethargy, ptosis, few faeces in pan, and yellow nasal discharge were sporadically noted in 3 animals. Eight out of thirteen animals appeared normal at all times. Lethargy was noted in two animals on day 0, but had cleared by day 1 and both animals then remained normal throughout the test. Slight weight loss was noted in the higher dose animals and dermal reactions were moderate to severe at the higher dose levels.

The acute dermal LD50 of the test material was therefore determined to be in excess of 8000 mg/kg.