Hydroxycyclohexyl phenyl ketone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug. 20, 1981 to Sep. 8, 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

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)

Deviations:

not specified

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxycyclohexyl phenyl ketone

EC Number:

213-426-9

EC Name:

Hydroxycyclohexyl phenyl ketone

Cas Number:

947-19-3

Molecular formula:

C13H16O2

IUPAC Name:

1-benzoylcyclohexan-1-ol

Test animals

Species:

rat

Strain:

other: Tif:RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy premises
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 182-200 g for males and 168-178 g for females
- Fasting period before study: overnight before treatment
- Housing: groups of 5 in Macrolon cages (type 3), marked individually
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG, Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 55+/-10%
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water containing 0.5% carboxymethyl-cellulose + 0.1% Polysorbat 80

Details on oral exposure:

Animals were treated orally, with a single dose by means of a stomach tube.

Doses:

1000, 2500, and 5000 mg/kg body wieght

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Clinical signs of toxicity, physical condition, and rate of death was monitored throughout the 14-day observation period.
The animals were submitted to a necropsy whenever they died, survivors at the end of the observation period.
Body weights were recorded immediately prior to dosing (control weights) and at days 7 and 14.

Statistics:

No statistics were performed.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

1 male in high-dose group died 2 days after treatment. 5 (all) females in the high dose group died (4 at 24 hours and 1 on day 3).

Clinical signs:

other: Clinical signs observed were dyspnea, exophthalmos, ruffled fur and curved body position. These clinical signs are common ef¬fects in this type of study. Beside that, some cases of sedation were observed within the first day after treatment. Additionally,

Gross pathology:

No test-article related changes were reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute oral LD50 was reported to be 2500 mg/kg body weight. The authors reported the test article to be slightly toxic to the rat by this route of adminstration.

Executive summary:

In this guideline (OECD 401) comparable study, the acute LD50 of the test material to rats was determined to be 2500 mg/kg bw via the oral route. A single dose of the test material was given to each animal (5 male, 5 female) via gavage. Animals were observed for 14 days from dosing. The result of the test does not trigger classification of the test material as acutely toxic under the criteria of the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).