(R)-1-hydroxy-1-phenylacetone

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

BASF Test

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(R)-1-hydroxy-1-phenylacetone

EC Number:

217-285-4

EC Name:

(R)-1-hydroxy-1-phenylacetone

Cas Number:

1798-60-3

Molecular formula:

C9H10O2

IUPAC Name:

(1R)-1-hydroxy-1-phenylpropan-2-one

Details on test material:

Name of test material: (-)-Phenylacetylcarbinol
- Physical state: liquid
- Analytical purity: 67.4 %

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: 4 weeks
- Weight at study initiation: 28 g (mean weight males), 22 g (mean weight females)
- Fasting period before study: 16 hrs
- Housing: 5 animals per cage,Macrolon cages
- Diet: Herilan, MRH-Haltung (H. Eggersmann KG, Rinteln), ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 26
- Humidity (%): 45- 75
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

(0.5 % aqueous solution)

Details on exposure:

VEHICLE
-Concentration in vehicle: 7 % for high dose, 2 % for low dose
- Justification of choice of vehicle: formulation according to the physiological medium
- Amount of vehicle: 10 mL/kg bw

Doses:

200, 700 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
- Frequency of weighing: before substance application, betweeen 2- 4 days, day 7, day 13 after substance application
- Frequency of observations: immediately after substance application (< 15 min), 15, 30, 60, 120, 240, 300 min after substance application then once per workday check for clinical symptoms. Twice per workday and once on other days check for dead and moribund animals.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 700 mg/kg bw

Based on:

test mat.

Remarks on result:

other: > 200 (1% significance level); < 700 (5 % signficance level)

Mortality:

200 mg/kg bw: 0/5 females and 0/5 males died
700 mg/kg bw: 4/5 males (at 1hr and 2 days post-dose) and 5/5 females (at 7 and 14 days post-dose) died

Clinical signs:

700 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, atony, unusual pain reflex, unusual corneal reflex, narcotic state, spastic walking, scrubby fur, ptosis, bad general state
200 mg/kg bw: dyspnoea, apathy, staggering, bad general state

Body weight:

200 mg/kg bw: body weight gain were within normal ranges
700 mg/kg bw: the one male that survived showed no body weight gain during the first 7 days; afterwards normal body weight increased until test ending; for the females, reduction in body weight was notice during the first 7 days.

Gross pathology:

dead animals:
no diagnosis possible

sacrificed animals:
no intraabdominal substance precipitation or conglutination

Any other information on results incl. tables

Table 1. Table of acute toxicity, intraperitoneal route
Dose [mg/kg bw]	Toxicological results*	Time of death	Mortality (%)
Males
200	0/5	--	0
700	4/5	1 hr, day 2	80
Females
200	0/5	--	0
700	5/5	day 7, day 14	100
* first number = number of dead animals, second number = number of animals used