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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 25 - March 10, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted to meet GLP regulations, however, the test followed standard guideline procedures (US Federal Hazardous Substances Labeling Act (FHSLA) 16 CFR 1500).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Acute Dermal Toxicity: FHSLA 16 CFR 1500.
Deviations:
not specified
GLP compliance:
no
Test type:
other: Limit test

Test material

Constituent 1
Chemical structure
Reference substance name:
barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)
EC Number:
939-718-2
Cas Number:
1474044-80-8
Molecular formula:
C28H44O3S.1/2Ba
IUPAC Name:
barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)
Test material form:
other: as solution in light paraffinic and naphthenic petroleum distillates
Details on test material:
A viscous brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
During the test period the animals were housed In Individual stainless steel wire bottomed cages in an environmentally controlled room. The
temperature was kept at 68 - 72 F. They were exposed to 12 hours of fluorescent light (8 A.M. - 8 P.M.) and 12 hours of darkness (8 P.M. -
8 A.M.) dai Iy. The animals were housed 1 per cage. Feed and water were provided ad-libitum after dosing.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The rabbits were prepared by clipping the skin of the trunk free of hair. Epidermal abrasions were made over a 5-6 cm2 area on 3 males and 2 females. The remaining five rabbits were not abraded. A non-permeable patch containing 2.0 ml/kg body weight of the test material was placed over a 4-5 cm2 area on all rabbits. The patches were secured in place with tape and an elastic sleeve. The rabbits were immobilized in head stocks for 24 hours at which time the patches were removed and the rabbits returned to their cages. Feed and water were provided ad-libitum. The rabbits were
observed for 14 days.
Duration of exposure:
24 hours

Results and discussion

Preliminary study:
A previouslyconducted study (Product Safety Labs Report No. T-348, April 4, 1978 ) demonstrated that application of a dermal dose of 20 ml/kg
the test substance produced 50% mortality.

Skin Sex Body Weight Dose Mortality
Treatment kg grams Test Day
Abraded M 2.7 54 2
Abraded M 2.8 56
Unabraded M 2.7 54 14
Unabraded M 2.7 54 3
Unabraded M 2.7 54 1
Abraded F 2.8 56 2
Abraded F 2.7 54 1
Abraded F 2.8 56 2
Unabraded F 2.8 56
Unabraded F 3.0 60 2
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortalities.
Clinical signs:
other: No signs of toxicity.
Gross pathology:
Not conducted due to lack of mortality.

Any other information on results incl. tables

Rabbit-No.

Sex

Body Weight-Initial kg

Body Weight-Final kg

Dose

ml/kg

3527-abraded

M

2.83

2.83

5.7

3528-abraded

M

2.58

2.71

5.2

3529-abraded

M

2.54

2.78

5.1

3530

M

2.80

3.19

5.6

3531

M

3.34

3.35

6.7

3576

F

2.68

3.03

5.4

3577-abraded

F

2.44

2.58

4.9

3578-abraded

F

2.32

2.45

4.6

3478

F

3.32

3.48

6.6

3479

F

3.00

3.00

6.0

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The Dermal LD50 of the test material is greater than 2.0 ml/kg for a 50% formulation. The LD50 as active ingredient is greater than 1000 mg/kg.
Executive summary:

A dermal acute toxicity test was conducted in New Zealand Albino Rabbits. Ten rabbits (5 male / 5 female) received a dose of 2 ml/kg bw of the test substance for 24 hours and were observed for 14 days for signs of toxicity and mortality. The skin of 5 rabbits was abraded prior to dosing (5-6 cm2 area on 3 males and 2 females). The Dermal LD50 of the test material is greater than 2.0 ml/kg. No mortality or toxic symptoms were observed. The LD50 as active ingredient is greater than 1000 mg/kg.