Phosphoric acid, C4 and C12-14(even-numbered) Alkyl Esters, Ammonium Salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 October 1987 to 06 November 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The approximate lethal dose (ALD) of test material was determined following administration of various doses to rats by gavage in a single dose. The ALD was defined as the lowest dose administered which caused death on the day of dosing or within 14-days post exposure.

GLP compliance:

yes

Test type:

other: lethal dose

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, mono-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Phosphoric acid, mono-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Constituent 2

Reference substance name:

Phosphoric acid, di-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Phosphoric acid, di-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Specific details on test material used for the study:

- Physical form: White to light tan paste
- Purity: 80 % active ingredient
- Lot: 751

Test animals

Species:

rat

Strain:

other: Crl:CDBR

Sex:

male

Details on test animals or test system and environmental conditions:

ANIMAL HUSBANDRY
- Male Crl:CDBR rats, approximately 7 weeks old, were received from Charles River Breeding laboratories, Kingston, New York.
- Rats were housed singly in suspended, stainless steel, wire-mesh cages.
- Each rat was assigned a unique identification number which was recorded on a card affixed to the cage.
- Purina Certified Rodent Chow #5002 and water were available ad libitum.
- Rats were quarantined, weighed and observed for general health for approximately one week prior to testing.
- Animal rooms were maintained on a timer-controlled 12-hour light and 12-hour dark cycle.
- Environmental targets for the animal rooms were 23 ± 2 °C and relative humidity of 50 ± 10 %. Excursions outside of these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

PROTOCOL
- The test material was suspended in distilled water and administered to one rat per dose rate by intragastric intubation.
- Dose rates administered ranged from 2300 to 11000 mg/kg bw in increments of approximately 50 %. Additionally, one rat was dosed at 670 mg/kg bw.
- The dosing day was test day one.
- Post-exposure day 14 was test day 15.
- Following administration of the test material, rats were observed for clinical signs of toxicity.
- Surviving rats were weighed and observed daily until signs of toxicity subsided and then at least three times per week during the 14-day post-exposure period.
- Observations were made daily throughout the study.

Doses:

670, 2300, 3400, 5000, 7500 and 11000 mg/kg bw

No. of animals per sex per dose:

One

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

other: approximate lethal dose

Effect level:

> 11 000 mg/kg bw

Based on:

test mat.

Mortality:

- No unplanned animal deaths took place during the study

Clinical signs:

other: NON-LETHAL DOSES - Rats dosed at 6709 or 2300 mg/kg bw exhibited no clinical signs of toxicity during the study. - Clinical signs of toxicity observed in rats dosed at 3400 to 11000 mg/kg bw were lung noise, lethargic behaviour, diarrhoea and yellow or br

Gross pathology:

- Not investigated

Any other information on results incl. tables

Dosage (mg/kg)	Dose volume (mL)	Suspension concentration (mg/mL)	Initial body weight (g)	Mortality
670	0.85	200	253	No
2300	2.8	200	243	No
3400	2.9	300	259	No
5000	4.1	300	247	No
7500	6.8*	300	272	No
11000	9.5*	300	260	No

* Administered in two portions, 15 minutes apart

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat. The material was considered to be very low in toxicity (ALD > 5000 mg/kg bw) when administered as a single oral dose.

Executive summary:

The approximate lethal dose (ALD) was investigated by administering 670, 2300, 3400, 5000, 7500 or 11000 mg/kg bw of test material to a male rat by gavage in a single dose under GLP conditions. No mortality was observed. Rats dosed at 6709 or 2300 mg/kg bw exhibited no clinical signs of toxicity during the study. Clinical signs of toxicity observed in rats dosed at 3400 to 11000 mg/kg bw were lung noise, lethargic behaviour, diarrhoea and yellow or brown stained perineum. Slight to severe weight losses (up to 13 % of initial body weight) were observed after dosing in most rats. Under the conditions of the study, the approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat. The material was considered to be very low in toxicity (ALD > 5000 mg/kg bw) when administered as a single oral dose.