Bis(2-ethylhexyl) phosphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Oct 2017 - 22 Jan 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

30 May 2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

GLP compliance:

yes

Remarks:

GLP-Landesleitstelle Bayer, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) phosphonate

EC Number:

222-904-6

EC Name:

Bis(2-ethylhexyl) phosphonate

Cas Number:

3658-48-8

Molecular formula:

C16H35O3P

IUPAC Name:

bis(2-ethylhexyl) phosphonate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-11 weeks
- Weight at study initiation: Step 1: 191 g - 200 g; Step 2: 161 g - 168 g
- Fasting period before study: 16 to 19 hours fasting prior to the admnistration
- Housing: Animals kept in groups in IVC cages, type III H, polysulphone cages on fibre bedding, full barrier in an air-conditioned room.
- Diet: ad libitum
- Water: drinking water, acidified to a PH value of approximately 2.8, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 × / hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: this vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: MKCC0462

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, and 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsic examination

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Three animals showed signs of toxicity 2 hours after administration of the test item. The most relevant clinical findings were reduced spontaneous activity, piloerection and half eyelid-closure. All symptoms recovered within the first day post-dose.

Gross pathology:

No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.

Conclusions:

The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 mg/kg bw.

Executive summary:

The acute oral LD50 cut-off for the test substance was determined in an OECD Guideline 423 test. Two groups, each of three female rats were successively dosed with 2000 mg/kg of test substance in corn oil. All animals surrvived until the end of the study. The acute oral LD50 cut-off of the test substance in female rats is >2000 mg/kg.