ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate

Endpoint summary

Description of key information

Only one acute toxicity is available on ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate : the acute oral LD0 was determined to be higher than 2 000 mg/kg bw.

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:

28 October 2014 to 02 December 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: For the purpose of the study the test material was freshly prepared as required as a suspension in arachis oil BP.
- Stability under storage conditions: The test material was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source : Harlan Laboratories UK Ltd., Oxon, UK.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: The body weight variation did not exceed ± 20 % of the body weight of the initially dosed animal.
- Fasting period before study: Yes. Animals were fasted overnight immediately before dosing and for approximately 3 - 4 hours after dosing.
- Housing: Animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Ad libitum, 2014C Teklad lobal Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK).
- Water: Ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): At least 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: The vehicle was selected as the test material did not dissolve/ suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2 000 mg/kg bw

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

All animals were dosed once only by gavage, using a metal canula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dose animals.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made half, 1, 2, and 4 hours after dosing and then daily thereafter for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on the day of dosing and on days 7 and 14.
- Necropsy of survivors performed: Yes. At the end of the observation period the animals were killed by cervical dislocation and all animals were subjected to gross necropsy, which consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance on any macroscopic abnormalities was recorded.

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Clinical signs:

other: Hunched posture and exophthalmos were noted in all animals. Tiptoe gait was also noted in two animals. Animals appeared normal 4 hours, 1 or 4 days after dosing.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study the acute oral LD0 of the test material was determined to be higher than 2 000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 420 and EU Method B.2 bis, under GLP conditions.

Following a sighting test at a dose level of 2 000 mg/kg, an additional four fasted female Wistar strain rats were given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2 000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Under the conditions of the study, none of the animals died. Hunched posture and exophthalmos were noted in all animals. Tiptoe gait was also noted in two animals. Animals appeared normal 4 hours, 1 or 4 days after dosing. Three animals showed expected weight gains over the observation period. Two animals showed body weight loss during the first week with expected gain in body weight during the second week. No abnormalities were noted at necropsy.

The acute oral LD0 of the test material was therefore determined to be higher than 2 000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

2 000 mg/kg bw

Quality of whole database:

A single study is available. The study was conducted in accordance with standardised guidelines and under GLP conditions and was therefore awarded a Klimisch reliability score of 1. The quality of the database is therefore considered to be high.

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

Acute Oral Toxicity

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 420 and EU Method B.2 bis, under GLP conditions.

Following a sighting test at a dose level of 2 000 mg/kg, an additional four fasted female Wistar strain rats were given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2 000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Under the conditions of the study, none of the animals died. Hunched posture and exophthalmos were noted in all animals. Tiptoe gait was also noted in two animals. Animals appeared normal 4 hours, 1 or 4 days after dosing. Three animals showed expected weight gains over the observation period. Two animals showed body weight loss during the first week with expected gain in body weight during the second week. No abnormalities were noted at necropsy.

The acute oral LD0 of the test material was therefore determined to be higher than 2 000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, no classification of ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate is required for acute toxicity according to the Regulation (EC) No 1272/2008.