Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 1500.3 – Federal Hazardous Substance Act Regulations – 16 CFR.
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts
EC Number:
270-478-5
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts
Cas Number:
68442-22-8
Molecular formula:
Too complex
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Source: Ace Animal, Inc. Boyertown, PA.
Age at study initiation: no data available.
Weight at study initiation: average weight between 200~300 g.
Fasting period before study: Feed was withheld overnight prior to dosing.
Housing: the animals were housed and maintained in accordance with standards set forth in the Guide for Care and Use of Laboratory Animals (DHEW publication No. 80-23). 5 rats/cage by sex.
Diet: Wayne Lab-Blox, provided ad libitum..
Water: tap water available ad libitum.
Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
Temperature (°C): 18.3~22.8 °C
Humidity (%): 45% ~ 55%
Air changes: no data available.
Photoperiod: 12 h light/dark cycle.

IN-LIFE DATES: From: 03/02/1983 To: 04/13/1983.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 and 5000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosage and twice daily thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter and prior to sacrifice. Individual weights were recorded on the day of dosage, and average groups weights were recorded at 7 and 14 days after dosing.
- Necropsy of survivors performed: gross necropsies were performed on all animals that either died during the 14 day observation period or on surviving animals that were sacrificed at the conclusion of the 14 day observation period.
Statistics:
no data available

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Mortality:
5000 mg/kg
Male: Number of animals: 5; Number of deaths: 5
Female: Number of animals: 5; Number of deaths: 5

2000 mg/kg
Male: Number of animals: 5; Number of deaths: 0
Female: Number of animals: 5; Number of deaths: 2
Clinical signs:
In the 2000 mg/kg dose group, all survival animals appeared normal.
Body weight:
All animals showed bodyweight gain.
Gross pathology:
No gross abnormalities were noted in all animals (either found dead during the study or in the animals necropsied at the conclusion of the study).

Any other information on results incl. tables

Table 1. Results

Dose Level (mg/kg)

5000

2000

Sex

Male

Female

Male

Female

Average Body Weight (g)

Initial

261

211

222

206

7 d

259

218

14 d

313

231

Mortality (No. death/No. dosed)

5/5

5/5

0/5

2/5

Table 2: Observations:

Sex

Dose (mg/kg)

Time after dosing

Observation

Male

2000

Up to 14 d

All animals appeared normal. 

5000

4 h

24 h

 

48 h

 

72 h

5/5 appeared normal

2/5 found dead; 3/5 appeared ruffled and exhibited depressed activity

1/5 found dead, 2/5 appeared ruffled and exhibited diarrhea.

2/5 found dead.

Female

2000 mg/kg

4 h

24 h

 

48 h

72 h – 14 d

5/5 appeared ruffled

1/5 appeared ruffled; 3/5 appeared ruffled and exhibited depressed activity

1/5 found dead;

3/5 appeared normal

5000 mg/kg

4 h

24 h

 

48 h

5/5 appeared normal

2/5 found dead; 3/5 appeared ruffled and exhibited depressed activity

3/5 found dead.

 

No gross abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test article, when administered as received to male/female Sprague-Dawley rats, had an acute oral LD50 of greater than 2000 mg/kg bodyweight but less than 5000
Executive summary:

In an acute oral toxicity study, 2 groups fasted Sprague-Dawley strain Albino rats (five male and five female) were given a single oral dose of undiluted test material at a dose level of 2000 and 5000 mg/kg bw and observed for14 days.

All animals died in the high dose group. In the low dose group, 2/5 female died on day 2; all the survived animals appeared normal. No gross abnormalities were noted in all animals (either found dead during the study or in the animals necropsied at the conclusion of the study). All animals showed expected bodyweight gain during the study period.

The oral LD50 value of test material in rats of both sexes has been determined to be greater than 2000 mg/kg bodyweight but less than 5000 mg/kg bodyweight.