Registration Dossier

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:
other: Non-guideline, non-GLP study

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

Constituent 1
Chemical structure
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
- Source:
- Age at study initiation:
- Weight at study initiation: 2.25-2.75 kg
- Fasting period before study:
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): approximately 4 ounces daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: plastic sheet


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- 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
- Concentration (if solution):
- Constant volume or concentration used:
- For solids, paste formed:


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
5000 mg/kg
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
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 bronchipnuemonia or chronic interstitial pneumonia. Two rabbits had small white liver abcesses that were determined to be of parasitic origin after histological examination.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information