Phosphoric acid, 2-ethylhexyl ester, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1987-02-25 to 1987-03-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, 2-ethylhexyl ester, sodium salt

EC Number:

269-044-8

EC Name:

Phosphoric acid, 2-ethylhexyl ester, sodium salt

Cas Number:

68186-64-1

Molecular formula:

C8 H18 O . x H3 O4 P . x Na

IUPAC Name:

.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by Cassella AG, label: CA 799

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna (U.K. ) Limited, l,lyton, HuntÍngdon, Cambrídgeshire
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 101 - 115 g, females 101 - 112 g
- Fasting period before study: overnight before dosing and appr. 2 hours after dosing
- Housing: solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum, Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 45-49
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.85 mL/kg

Doses:

one (limit) dose of 2000 mg/kg bw was applied

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 hours following dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation. Individual bodyweights were recorded on the day of treatment (day 0) and days 7 and 14.
- Necropsy of survivors performed: All animals were subjected to a gross necropsy examination for any macroscopic abnormalities. No tissues were retained.

Statistics:

statistical evaluation as not necessary

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured

Clinical signs:

other: no signs of systemic toxicity were noted

Gross pathology:

Small white raised areas approximately 1 mm x 1 mm were noted on approximately half of the non-glandular region of the stomach at necropsy of four surviving animals killed at the end of the study. No anormalities were noted at the necropsy of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value of the test material was found to be >2000 mg/kg bw.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test material in the rat according to OECD Guideline No 401. Five male and five female Sprague-Dawley CFY strain rats were used.

All animals were dosed once only by gavage with a limit dose of 2000 mg/kg bw. The animals were observed for a period of 14 days. As a result, no mortality occurred and no signs of systemic toxicity were noted. Therefore, the LD50 of the test material was considered to be >2000 mg/kg bw.