(R)-1-hydroxy-1-phenylacetone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to an internal BASF Test method, which in principle was similar to OECD TG 401; GLP was not compulsory at the time the study was conducted.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The study was conducted according to a BASF Testing method, which in principle was similar to the OECD TG 401.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test type:

standard acute method

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 (as cited in study report): (-)-Phenylacetylcarbinol
- Physical state: liquid
- Analytical purity: 67.4 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Willi Gassner, Sulzfeld
- Age at study initiation: about 12 weeks
- Weight at study initiation: 150 g (females, mean weight), 175 g (males, mean weight)
- Fasting period before study: 16 hrs
- Housing: 5 animals/cage, steel wire-mesh cages (FA. Becker & Co., Castrop-Rauxel)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

(0.5 % in aqueous solution)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 46.4, 31.6, 21.5, 14.7, 10.0 % (g/v) for doses 4640, 3160, 2150, 1470 and 1000 mg/kg bw
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: equivalent to physiological medium

Doses:

1000, 1470, 2150, 3160, 4640 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: shortly before study, between day 2 and 4, day 7, day 13 after application
- Frequency of observations: immediately after substance application (< 15 min), 15, 30, 60, 120, 240, 300 min after substance application, afterwards check for clinical symptoms once per workday. Twice daily on workdays 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:

> 1 470 - < 2 150 mg/kg bw

Based on:

test mat.

Mortality:

1000 mg/kg bw: 0/5 females and 0/5 males died
1470 mk/kg bw: 0/5 males and 2/5 females (at 2 d post-dose) died
2150 mg/kg bw: 4/5 males (at 1 d post-dose), 4/5 females (at 1 d post-dose) died
3160 mg/kg bw: 5/5 males (at 1- 48 hrs post-dose), 5/5 females (at 1- 48 hrs post-dose) died
4640 mg/kg bw: 5/5 males (at 1- 24 hrs post-dose), 5/5 females (at 1- 24 hrs post-dose) died

Clinical signs:

other: 1000 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, atony, unusual pain reflex, unusual corneal reaction, narcotic state, ruffled fur, erythema, exsiccosis, bad general state 1470 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, aton

Gross pathology:

sacrificed animals: no findings
dead animals:
- in heart: acute dilatation of ante-chamber, acute congestive hyperaemia
- stomach: atonic liquid stomach content

Any other information on results incl. tables

Table 1. Table for acute oral toxicity.
Dose [mg/kg bw]	Toxicological results*	Time of death	Mortality (%)
Males
1000	0/5	---	0
1470	0/5	---	0
2150	4/5	Day 1	80
3160	5/5	1 hr, day 1, day 2	100
4640	5/5	1hr, Day 1	100
Females
1000	0/5	---	0
1470	2/5	day 2	40
2150	4/5	day 1	80
3160	5/5	1 hr, day 1, day 2	100
4640	5/5	1hr, Day 1	100
* first number = number of dead animals
second number = number of animals used

Table 2: Mean body weights (g) of surviving male and female rats over 14 days of observation
Males
Doses (mg/kg bw)	4640	3160	2150	1470	1000
Initially	170	170	180	180	180
Day 2 to 4	n.a.*	n.a.	184	197	212
Day 7	n.a.	n.a.	217	237	244
Day 13	n.a.	n.a.	258	272	270
Females
Doses (mg/kg bw)	4640	3160	2150	1470	1000
Initially	150	150	150	150	150
Day 2 to 4	n.a.*	n.a.	169	157	176
Day 7	n.a.	n.a.	182	185	188
Day 13	n.a.	n.a.	193	201	200
* not applicable because of 100% mortality