Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
non GLP, no bw developement, no necropsy, considered of minor importance due to absence of mortality and overt signs of toxicity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A pilot acute oral toxicity study carried out on groups of 4 young adult rats (2 male, 2 female) at dose levels of 2.5, 5 and 10 ml/kg, followed by an acute oral toxicity study carried out on a group of 10 young adult rats (5 female, 5 male) at a dose level of 5 ml/kg. The rats were weighed in groups of 2 or 5 and the average bodyweight used to calculate the volume administered.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate
EC Number:
275-965-6
EC Name:
Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate
Cas Number:
71735-74-5
Molecular formula:
C11H23O4PS2
IUPAC Name:
ethyl 3-{[bis(propan-2-yloxy)(sulfanylidene)-λ⁵-phosphanyl]sulfanyl}propanoate

Test animals

Species:
rat
Strain:
other: Sprague-Dawley derived rats of the C.D. strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K. ) Limited, Margate, Kent, UK
- Weight at study initiation: 220-300g
- Housing: groups of 2 (pilot study) or 5 (main study) in plastic cages
- Diet: Oxoid Breeding Diet supplied by Herbert C. Styles (Bewdley) Limited, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 +/- 1
- Humidity (%): 50-70

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A pilot acute oral toxicity study carried out on groups of 4 young adult rats (2 male, 2 female) at dose levels of 2.5, 5 and 10 mL/kg. 50% mortality was observed at the highest dose level (10 mL/kg) and no deaths at 2.5 and 5 ml/kg.
Doses:
2,5, 5 and 10ml/kg in the pre-test
5 mL/kg in the main test
No. of animals per sex per dose:
2 in the pre-test
5 in the main test
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: The animals were observed for signs of toxicity at hourly intervals for the 8 hours following treatment and daily for the subsequent 14 days.

Results and discussion

Preliminary study:
In the pilot study 50% mortality was observed at the highest dose level (10 mL/kg). No deaths occurred in rats treated at 2.5 and 5mL/kg.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Mortality:
50% at 10 mL /kg in the pilot study.
Clinical signs:
other: The two animals dying in the pilot study were lethargic and adopted a hunched stance 24 hours after treatment which persisted until death. No overt signs of toxicity w ere observed in the surviving animals.
Gross pathology:
not performed

Any other information on results incl. tables

Dose Level (mL/kg) Animals Average weight (g) Volume dosed (mL) Number surviving
Pilot study



day 1 2 3 4 5 6 7 -14 
2.5
2 male 300 0.75
2 2 2 2 2 2 2
2 female 250 0.63
2 2 2 2 2 2 2
5
2 male 250 1.25
2 2 2 2 2 2 2
2 female 250 1.25
2 2 2 2 2 2 2
10
2 male 300 3
2 2 1 1 1 1 1
 
2 female 220 2.2
2 1 1 1 1 1 1
Main study










5
5 male 250 1.25
5 5 5 5 5 5 5
5 female 220 1.1
5 5 5 5 5 5 5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of the test substance is likely to be in excess of 5 ml/kg.
Executive summary:

An acute toxicity test on Sprague Dawley rats was performed to assess the toxic potential of the test substance after oral ingestion. In a pilot study carried out on groups of 4 young adult rats (2 male, 2 female) at dose levels of 2.5, 5 and 10 ml/kg, 50% mortality was observed at the highest dose level. No deaths occurred in rats treated at 2.5 and 5 ml/kg. The following main study was performed with a group of 10 young adult rats (5 female, 5 male) at a dose level of 5ml/kg, in which no mortalities were reported. Bases on this result, the test article is considered to be practically non toxic after a single oral ingestion.