Rectified Hydrocarbons by-products from synthetic process of Turpentine and acid

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

The study does not meet the main criteria of the specific testing guideline (duration, number of tested animals, haematology, clinical biochemistry, gross necropsy, etc.)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In this study, the effect of camphene on serum lipids and apolipoproteins (apoproteins) was investigated in male Wistar rats in order to obtain more information on the physiological role of essential oils. Camphene was mixed with the powdered commercial rat ration at the level of 1%. A control group received the commercial rat ration alone. Three or four rats were used. The rats were fasted overnight prior to blood sampling from the abdominal aorta. Serum lipids and apoproteins were determined.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Camphene

EC Number:

201-234-8

EC Name:

Camphene

Cas Number:

79-92-5

Molecular formula:

C10H16

IUPAC Name:

2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kyudo Co., Kumamoto
- Weight at study initiation: 248 ± 4.1 g
- Housing: The animals were kept in an air conditioned room
- Diet (e.g. ad libitum): ad libitum; NMF, Oriental Yeast Co, Tokyo.
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Camphene was mixed with the powdered commercial rat ration.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

14 Days

Frequency of treatment:

Daily

Doses / concentrations

Dose / conc.:

500 mg/kg bw/day (nominal)

Remarks:

Basis: 1 % of camphene mixed in diet

No. of animals per sex per dose:

3-4 male rats per group

Control animals:

yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Not specified

DETAILED CLINICAL OBSERVATIONS: Not specified

BODY WEIGHT: Yes
- Time schedule for examinations: at beginning and at the end of study

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At the end of study.
- Animals fasted: Yes. The rats were fasted overnight prior to blood sampling.
- How many animals: 3-4
- Parameters examined: Serum lipids (cholesterol and triacylglycerol) and apoproteins (Apo A-I)

OTHER: RELATIVE LIVER WEIGHT
- Time schedule for collection of blood: At the end of study.

Sacrifice and pathology:

GROSS PATHOLOGY: No

HISTOPATHOLOGY: No

Statistics:

Student's t test.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Description (incidence and severity):

No significant differences were observed in body weight gain between treated and control animals.

Food consumption and compound intake (if feeding study):

no effects observed

Description (incidence and severity):

No significant differences were observed in food consumption between treated and control animals.

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

no effects observed

Description (incidence and severity):

No significant differences in cholesterol, triacylglycerol and Apolipoprotein Apo A-I were observed between treated and control animals.

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

effects observed, non-treatment-related

Description (incidence and severity):

Liver weight per 100 g of body weight tended to increase by the supplementary essential oils. No significant increase was recorded for the test item.

Gross pathological findings:

not examined

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Other effects:

not examined

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

>= 500 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

clinical biochemistry

Target system / organ toxicity

Key result

Critical effects observed:

no

Any other information on results incl. tables

After 14 days, the NOAEL was equal or greater than 500 mg/kg bw/day for male rats.

Applicant's summary and conclusion

Conclusions:

After 14 days of oral exposure, the NOAEL of camphene was equal or greater than 500 mg/kg bw/day for male rats.

Executive summary:

The effect of camphene on serum lipids and apolipoproteins (apoproteins) was investigated in male Wistar rats in order to obtain more information on the physiological role of essential oils. Camphene was mixed with the powdered commercial rat ration at the level of 1% (ca. 500 mg/kg bw/day). It was daily administered for 14 days. A control group received the commercial rat ration without test substance. Three or four rats were used. The rats were fasted overnight prior to blood sampling from the abdominal aorta. Serum lipids and apoproteins were determined. No significant differences were observed in body weight gain and/or food consumption between treated and control animals. Liver weight per 100 g of body weight tended to increase by the supplementary essential oils but not significantly. No significant differences in cholesterol, triacylglycerol and Apolipoprotein Apo A-I were observed between treated and control animals. Thus, the NOAEL of camphene was equal or greater than 500 mg/kg bw/day for male rats.