cyclohexadecanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 28 Feb 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(Commission Directive 96/54/EC)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

438-930-8

EC Name:

-

Cas Number:

2550-52-9

Molecular formula:

C16H30O

IUPAC Name:

cyclohexadecanone

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 233.7 ± 10.0 g (males), 193.7 ± 17.9 g (females)
- Fasting period before study: overnight, and until 3 h after administration
- Housing: individually in Makrolon Type 3 cages, granulated soft wood bedding
- Diet: ALTROMIN 1324, pelleted standard diet (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 23.5
- Humidity (%): 30 - 40, with a shortly falling below to 23%
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 g/10 mL
- Amount of vehicle: 1 mL/100 g bw

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw

CLASS METHOD
- Rationale for the selection of the starting dose: The study was performed as limit test.

Doses:

2000 mg/kg bw (step 1 and 2)

No. of animals per sex per dose:

3 males (step 1) and 3 females (step 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality, morbidity and general clinical condition continuously on the day of administration and subsequently once daily for 14 days. The following signs were given predominant consideration: changes in skin, fur, eyes and mucous membranes; gait and posture; respiratory, circulatory, autonomic and central nervous system; occurrence of secretions and excretions; presence of clonic or tonic movements and stereotypies or bizarre behaviour. Body weights were recorded 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight

Statistics:

Body weights and body weight gain: Calculation of group mean values and standard deviations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the course of the study.

Clinical signs:

Not any alterations of the general state of well-being were observed during the course of the study.

Body weight:

The body weight gain was not affected by the administration of the test item, it was in the range of the historical control data in the testing facility. The body weight gain of one female animal was retarded in comparison to the historical control data in the testing facility but it can be assumed that this is not caused by the administration of the test item and seems to be accidental.

Gross pathology:

There were no macroscopic pathological findings in the animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.

Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423, EU Method B.1 tris and in compliance with GLP (2001). A total dose of 2000 mg/kg bw (limit test) test substance was administered to 3 male (1st step) and 3 female rats (2nd step). Animals were observed for mortality and general clinical condition on the day of administration and once daily thereafter for 14 days. Body weights were recorded on the day of administration and on days 7 and 14 thereafter. Macroscopic examination was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical symptoms were observed during the study. The body weight gain was not affected by the administration of the test substance. The body weight gain of one female animal was retarded in comparison to the historical control data in the testing facility but it can be assumed that this is not caused by the administration of the test substance and seems to be accidental. No pathological findings were observed at necropsy. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats.