Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(occlusive)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)

EC Number:

224-235-5

EC Name:

Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)

Cas Number:

4259-15-8

Molecular formula:

Too complex

IUPAC Name:

1-Hexanol, 2-ethyl-, O,O-diester with phosphorodithioic acid, zinc salt

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.25-2.75 kg
- Housing: Housed individually in wire bottom cages
- Diet: approximately 4 ounces daily
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 100%
- Type of wrap if used: plastic sheet

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: test material removed 24 hours after exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg bw

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: thymus, heart, lungs, liver, kidneys, adrenal glands, spleen, gonads, gastro-intestinal tract, lymph nodes, pancreas, salivary glands, bladder, body fat, skeletal muscle, teeth, eyes and skin.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

One animal with abraded skin died 13 days after dosing

Clinical signs:

Severe erythema and edema noted at 24 hours. By seven days treated sites were thick and escharotic.

Body weight:

Treated animals weighed significantly less than controls.
Average body weight during study
Control: 2.47 kg (start), 2.49 kg (day 7), 2.85 kg (day 14
Treated: 2.44 kg (start), 2.15 kg (day 7), 2.15 kg (day 14)
Note: Values are an average of 6 rabbits except for day 14 treated, which is the mean of 5 animals

Gross pathology:

Liver-like or necrotic-appearing areas of lung tissue observed in five rabbits. Further histology of the lungs revealed confluent bronchipneumonia or chronic interstitial pneumonia. Two rabbits had small white liver abscesses that were determined to be of parasitic origin after histological examination.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

CLP: not classified