Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct - Nov 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

EC Number:

287-619-1

EC Name:

Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

Cas Number:

85563-48-0

Molecular formula:

C20H44NO.H2O4P

IUPAC Name:

dihydrogen hexadecyl(2-hydroxyethyl)dimethylazanium phosphate

Constituent 2

Reference substance name:

Cetyldimethyl(2-hydroxyethyl)ammonium dihydrogen phosphate

IUPAC Name:

Cetyldimethyl(2-hydroxyethyl)ammonium dihydrogen phosphate

Test material form:

other: liquid

Details on test material:

Name of the test substance used in the study report: FAT 75174/A

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Body weight range: 157 - 203 g
Initial age: 7 - 8 weeks
Animal identification: colour code using picric acid
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 3 with standardized soft wood bedding.
The animal room was air conditionned: temperature 22+/-3°C, relative humidity 55+/- 15%, 12 hours light/day, approximately 15 air changes/h.
A standardized animal laboratory diet as well as water were available ad libitum. Prior to dosing, the animals were fasted overnight.
Source: Ciba-Geigy LTD. Tierfarm, Sisseln Switzerland
Diet: Rat food, NAFAG No. 890, Gossau, Switzerland, provided ad libitum
Water: tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Application volume: 10 ml/kg

Doses:

500, 1000, 2500, 5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observation period: 14 days
Daily check for mortality (a.m.and p.m.) on working days.
Daily check for signs and symptoms.
Body weight determination on days 1, 7, 14 and at death
Spontaneously died animals were subjected to a gross necropsy as soon as possible; survivors at the end of the observation period.
Prior to dosing, the animals were fasted overnight.

Statistics:

yes
From the body weights, the group means and their standard deviations were calculated. Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am.Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 639 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2 029 mg/kg bw

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

3 080 mg/kg bw

Mortality:

Male animals: 500, 1000, 2500 mg/kg: no deaths; 5000 mg/kg: 5/5
Female animals: 500 and 1000 mg/kg: no deaths; 2500 mg/kg: 3/5; 5000 mg/kg: 5/5

Clinical signs:

Highest concentration: sedation, dyspnea, exophtahalmos, ruffled fur, vental and curved body position, tonic/clonic muscle spasm.
The surviving animals recovered within 9 - 13 day.

Body weight:

Mean body weight male animals: 180 g at study start, 275 g after 14 days
Mean body weight female animals: 171 g at study st art, 225 g after 14 days

Gross pathology:

No compound-related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the rat was estimated to be greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was investigated in rats according to the OECD guideline No 401. The test item was administered orally by gavage to 5 males and 5 females per dose group. Four different concentrations were examined (500, 1000, 2500 and 5000 mg/kg bw). No death occurred in males after administration of 500, 1000 and 2500 mg/kg bw. After administration of 500 and 1000 mg/kg bw in females no deaths were observed, too. 3 out of 5 females dosed with 2500 mg/kg bw of the test item died within 2 days after application. After administration of 5000 mg/kg bw all animals (males and females) died within 3 hours. No compound related gross organ changes were observed. The acute oral median lethal dose (LD50) of the test item in the rat was estimated to be greater than 2000 mg/kg bw.