Phosphoric acid, mono- and di-C16-18 (even numbered) alkyl esters, salts with 2,2'-iminodiethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine

Cas Number:

68425-57-0

Molecular formula:

not applicable

IUPAC Name:

Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine

Test material form:

solid: crystalline

Details on test material:

Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine
CAS No.: 68425-57-0
Physical state: white solid at 20 °C (turbid, non-pourable paste)

Specific details on test material used for the study:

Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine (Phosphorsaeure (C8-C10-Alkyl)-ester, DEA-Salz)
CAS No.: 68425-57-0 (68186-45-8)
Physical state: white solid at 20 °C (turbid, non-pourable paste)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:

Species/strain: healthy Wistar rats
Source: Fa. Winkelmann, Borchen, Germany
Sex: male and female

Age at the beginning of the study: 15 months

Number of animals: 2 per sex

Housing and Feeding Conditions:

- Temperature: 20 - 25 °C
- Relative humidity: 45 - 60%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: not specified
- Free access to Altromin-Haltungsdiät 1324
- Free access to tap water (drinking water)
- two animals per cage (Makrolon 3)
- Adequate acclimatisation period (at least 1 week) under laboratory conditions

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other:

Remarks:

1 % Carboxymethylcellulose and 0.5 % Cremophor

Details on oral exposure:

The test item was administered at a dose volume of 10 mL/kg body weight. The test item was administered at a single dose by gavage using a feeding tube.

Doses:

The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal.

No. of animals per sex per dose:

two rats per sex

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (total fraction)

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All animals survived until the end of the study without showing any test-item related signs of toxicity.

Clinical signs:

other: All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality. There were no specific findings during the whole observation period.

Gross pathology:

At the end of the observation period the animals were sacrificed with diethylether. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes.

Any other information on results incl. tables

Results

Table 1: Mean Body Weights of test animals

Animals / sex	Starting dose (mg/kg bw)	mean bodyweight (g)
		Day -1	Day 1	Day 2	Day 7	Day 14
2 / female	2000	168	161	169	165	172
2 / male	2000	206	189	214	234	279

The acute oral toxiclty of the test item was investigated in young Wistar rats, breeder Winkelmann, Borchen. The test compound was administered by single gavage in 1 % Carboxymethylcellulose and 0.5 % Cremophor as solvent and an application volume of 10 ml kg-1 body weight to fasted animals. Two rats were used per sex. Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The LD50 dose of the test item after a single oral administration to male and female rats, observed over a period of 14 days is, according to OECD Guideline 401 is greater than 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 dose of the test item after a single oral administration to male and female rats, observed over a period of 14 days is, according to OECD Guideline 401 is greater than 2000 mg/kg.

Executive summary:

The acute oral toxiclty of the test item was investigated in young Wistar rats, breeder Winkelmann, Borchen. The test compound was administered by single gavage in 1 % Carboxymethylcellulose and 0.5 % Cremophor as solvent and an application volume of 10 ml kg-1 body weight to fasted animals. Two rats were used per sex. Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The LD50 dose of the test item after a single oral administration to male and female rats, observed over a period of 14 days is, according to OECD Guideline 401 is greater than 2000 mg/kg.