Zinc bis[bis(tetrapropylenephenyl)] bis(hydrogen dithiophosphate)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline stated, however study appears to have been well conducted and appears to be similar to OECD 402. The study predates GLP. No details on test material.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Animals were tested with and without abrasion to skin.

Principles of method if other than guideline:

- Only 4 animals with intact skin were used per dose.
- Occlusive dressings were used.

GLP compliance:

no

Remarks:

pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

No data

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.4 - 2.3 kilograms
- Housing: Throughout the observation period the animals were housed individually in metal cages with wire mesh floors elevated above the droppings
- Diet/water: Feed and water were available at all times.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: Undiluted test material was applied under rubber dental damming. The trunks of the animals were wrapped securely with gauze and adhesive tape binders to prevent ingestion of the applied material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Abdominal skin areas were sponged with Wesson Oil to remove any residue.
- Time after start of exposure: 24 hours

Duration of exposure:

24 hour

Doses:

The dosage levels tested were 10.3, 15.4, 20.5, and 25.6 g/kg of body weight.

No. of animals per sex per dose:

4 with intact skin and 4 with abraded skin per dose level.

Control animals:

not specified

Results and discussion

Preliminary study:

n/a

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 25 600 mg/kg bw

Based on:

test mat.

Mortality:

There were no fatalities at any dosage level tested.

Clinical signs:

other: The animals at all dosage levels tested exhibited normal behavior during the day of application of the test material and daily thereafter, throughout the study.

Gross pathology:

Gross autopsies performed upon each of the animals at termination of the study revealed normal internal organs and body cavities.

Other findings:

The 24-hour exposure to the test compound produced a moderate degree of dermal irritation characterized by severe erythema and edema. These signs, in general, had subsided within nine or 10 days following removal of the binders. Beginning at this time however, the treated skin areas showed drying, and desquamation was observed which persisted throughout the remainder of the observation period.

Any other information on results incl. tables

The study also tested the Dermal Application of abraded Skin, however it should be noted that these results are not suitable for classification according to recognised guidelines. The results are as follows:

No fatalities attributable to the test compound occurred at any dosage level tested. A single fatality which occurred at the 10.3 g/kg level within 12 to 24 hours following dosage was attributed to a previously contracted gastro-intestinal disorder. The acute dermal LD50 of the test material when applied to the abraded skin of rabbits is therefore greater than 25.6 g/kg of body weight.

With the exception of the fatality at the low level, each of the animals exhibited normal behavior during the day of application of the test material and daily thereafter throughout the 14-day observation period. In addition, each of the animals maintained or showed an increase over its respective initial body weight.

The 24-hour exposure to the test compound produced on the abraded rabbits a moderate degree of skin irritation characterized by severe edema and erythema. In addition, the abrasions showed purulent exudates. The exudates had dried and the abrasions had begun to heal within an additional two or three days. The erythema and edema had in general subsided within nine or 10 days. At this time, however, the treated skin areas showed appreciable drying accompanied by desquamation; these signs persisted thereafter.

Gross autopsies performed upon each of the animals at termination of the study revealed normal internal organs and body cavities.

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 when applied to the intact skin of rabbits is greater than 25.6 g/kg of body weight.

Executive summary:

Eight groups of four albino rabbits of either sex, weighing between 1.4 and 2.3 kilograms (kg) were used to evaluate the dermal toxicity of the test material. Four dosage levels were administered; each level was administered to a group of four animals whose closely clipped abdominal skin was left intact and to a corresponding abraded group. The dosage levels tested were 10.3, 15.4, 20.5, and 25.6 g/kg of body weight. The sites were occluded for 24 hours and then the dressings were removed and the sites washed with Wesson oil.

For the intact skin doses there were no deaths, signs of toxicity, weight loss or gross abnormalities at any dose level tested.

The acute dermal LD50 of the test material when applied to the intact skin of rabbits is greater than 25.6 g/kg of body weight.

The test material is dermally non-toxic within the meaning of the Federal Hazardous Substances Labeling Act.