Dibutyl [(dipropoxyphosphinothioyl)thio]succinate

Endpoint summary

Description of key information

The acute oral median lethal dose (LD₅₀) of test material in the Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight (SafePharm Laboratories, 2004).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 March 2004 – 11 May 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

- Description: Light amber coloured, slightly viscous liquid
- Storage: Room temperature, in the dark

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Eight to twelve weeks
- Weight at study initiation: 188 to 210 g
- Fasting period before study: An overnight fast immediately before dosing
- Housing: Suspended solid-floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK
- Water (e.g. ad libitum): Free Access to mains drinking water (tap water, ad libitum)
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

IN-LIFE DATES: From: 18 March 2004 To: 03 April 2004

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

3 animals per dose

No. of animals per sex per dose:

3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for deaths or overt signs of toxicity ½, 1, 2, and 4 hours after dosing, and subsequently once daily for fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no unscheduled deaths.

Clinical signs:

other: Signs of systemic toxicity noted in three animals were hunched posture, diuresis, diarrhoea, and dehydration. These animals recovered six or seven days after dosing. The remaining three animals appeared normal throughout the study.

Gross pathology:

No abnormalities were noted at necroscopy.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 for female Sprague Dawley CD strain rats was found to be greater than 2500 mg/kg body weight. The study was performed to the standardised guideline OECD 423, under GLP conditions.

Executive summary:

The acute oral LD50 for female Sprague Dawley CD strain rats was found to be greater than 2500 mg/kg body weight.

 

No unscheduled deaths and no signs of systemic toxicity were noted during the observation period. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.

 

The study was performed to the standardised guideline OECD 423, under GLP conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Key study:

In an OECD Guideline 423 study, conducted according to GLP, the acute oral median lethal dose (LD₅₀) of the test substance in the Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight (SafePharm Laboratories, 2004).