Phosphorous acid, tri-C12-14-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following the guideline without any deviation but not performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

not specified

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Phosphorous acid, tri-C12-14-alkyl esters

EC Number:

297-701-9

EC Name:

Phosphorous acid, tri-C12-14-alkyl esters

Cas Number:

93686-48-7

Molecular formula:

C36H75O3P C38H7903P C40H83O3P C42H87O3P

IUPAC Name:

Phosphorous acid, tri-C12-14-alkyl esters

Test material form:

other: liquid

Details on test material:

purity > 98%
batch number: A

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: élevage JANVIER, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 188 to 206 g
- Fasting period before study: the day before the treatment
- Housing: 3 animals per polycarbonate cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15 volume per hour
- Photoperiod: 12 hrs dark/ 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: dose applied: 2000 mg/kg bw, corresponding to 2,32 mL/ kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females for the first administration and then 3 other females for confirmation

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for clinical signs and weighing at days 0, 2, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study

Clinical signs:

other: no clinical signs detected

Gross pathology:

only white thickening of the stomach mucosa was found in 3 female / 6

Other findings:

no other findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, a oral LD50 cutt off > 5000 mg/kg bw was considered for Phosphorous acid, tri-C12-14-alkyl esters.

Executive summary:

Phosphorous acid, tri-C12-14-alkyl esters was tested in a acute toxicity class method, according to OECD 423 test guideline and without any deviation. The study was considered as reliable but was not performed under GLP conditions and a reliability 2 was then associated.

Six female Sprague Dawley rats were given 2000 mg/kg bw test substance by gavage and no clinical sign nor behaviour comportment were found. No mortality occured even after 14 day observation period.

Phosphorous acid, tri-C12-14-alkyl esters was then considered as not harmful if swallowed and could be not classified for this endpoint, according to the GHS classification criteria.