Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 13, 1981 - December 2, 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

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:

Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

EC Number:

279-632-6

EC Name:

Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Cas Number:

80939-62-4

Molecular formula:

Unspecified

IUPAC Name:

Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

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:

TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, CH-4332 Sisseln
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 - 190 g
- Fasting period before study: over night, prior to dosing
- Housing: groups of 5 in macrolon cages type 3 with standardized soft wood bedding
- Diet: rat food, Nafag No. 890
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes

Statistics:

For the body weights, the group means and their standard deviation were calculated.
The LD50 including the 95 % confidence limit were computed by the logit method.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1 female animal died 2 days post application.

Mortality:

1 female animal died 2 days post application.

Clinical signs:

other: Dyspnoea, ruffled fur and curved body position were observed directly after application and lasted up to day 7 post application. For several hours or days, respectivley, sedation and diarrhoea was also observed. All clinical signs were reversible within t

Gross pathology:

No compound related gross organ changes were observed.

Any other information on results incl. tables

Table 1: Body Weights (g) and Standard Deviation

Dose (mg/kg bw)	Day 1	Day 7	Day 14
	Males
5000	182 (5.8)	206 (9.3)	250 (15.7)
	Females
5000	171 (5.2)	178 (6.9)	202 ( 5.5)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 of > 5000 mg/kg bw was determined in the rat.