(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 March 1989 to 13 April 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

EC Number:

701-394-3

Cas Number:

1782069-81-1

Molecular formula:

C18H22O

IUPAC Name:

(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

Test animals

Species:

rat

Strain:

other: Fü-albino SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Males about 6 weeks, females 6 to 7 weeks.
- Weight at study initiation: Males 125.0 to 132.7 g, females 125.0 to 140.6 g.
- Fasting period before study: About 18 hours.
- Housing: Individually caged.
- Diet: NAFAG standard rat maintenance diet, ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 45 to 65 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Standard Suspending Vehicle (SSV)

Remarks:

1000 mL SSV contains 5 g sodium carboxy methyl cellulose (medium viscosity), 4 mL Tween 80, 5 mL benzylalcohol pro analysi, 9 g sodium-chloride pro analysi and distilled water.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage):

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weigth

DOSAGE PREPARATION: The test article was kept suspended in Standard Suspending Vehicle (SSV) using a homogeniser. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 16 days
- Frequency of observations and weighing: Mortality was recorded continuously and body weight was recorded on days 0 (immediately before treatment), 2, 6, 9, 13 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Behaviour, vivacity, signs of injury, signs of sickness and abnormality were performed repeatedly on the treatment day and daily during the treatment-free observation period.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No autopsy findings were seen.

Any other information on results incl. tables

Table 1. Body weights

Sex	Mean body weights in g (standard deviation)
n = 5	Day 0	Day 2	Day 6	Day 9	Day 13	Day 15
Male	129.2 (2.8)	157.9 (4.2)	187.8 (6.2)	206.4 (8.1)	225.4 (9.2)	210.0 (9.1)
Female	130.2 (6.2)	147.5 (7.3)	159.2 (9.8)	165.8 (8.0)	174.4 (8.9)	164.0 (9.8)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 in rats was determined to be > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was determined in a 16 -day limit test conducted according to OECD 401. Male and female Fü-albino SPF rats, 6 to 7 weeks old, were dosed with the test item at a nominal concentration 2000 mg/kg bodyweight in Standard Suspending Vehicle by oral gavage. The dose volume was 10 mL/kg. Rats were observed for mortality and clinical signs and body weight. The LD50 was determined to be > 2000 mg/kg bw. There were no effects in body weight development and no clinical signs or autopsy findings were recorded. This study is considered reliable without restriction (Klimisch 1).