Reaction mass of Terpenes and Terpenoids, turpentine-oil, limonene fraction, 1-methyl-4-(1-methylethenyl)cyclohexene and turpentine-oil beta-pinene fraction terpenes, dimers and Terpenes and Terpenoids, turpentine-oil, limonene fraction, 1-methyl-4-(1-methylethenyl)cyclohexene and turpentine-oil beta-pinene fraction terpenes, trimers

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Principles of method if other than guideline:

Limit test at 1 dose level

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers

IUPAC Name:

Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers

Constituent 2

Reference substance name:

Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers

EC Number:

500-245-8

EC Name:

Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers

Cas Number:

70750-57-1

Test material form:

other: clear viscous honey-like liquid

Details on test material:

- Name of test material (as cited in study report): Zonarez A-25
- Physical state: Clear viscous honey-like liquid
- Analytical purity: Not reported
- Lot/batch No.: AIA804

Specific details on test material used for the study:

Test material: Zonares A25
Batch Number: AIA804
Date of receipt: 15 January 2018
Handling Instructions: Standard precautions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts
- Age at study initiation: Not reported
- Weight at study initiation: Male: 225-275 grams (before fasting)
- Fasting period before study: 18 hrs
- Housing: Individual stainless steel1/2 wire mesh cages.
- Sanitization: Waste material was removed daily. Cages and feeders were sanitized every two weeks
- Diet (e.g. ad libitum): Purina Certified Rodent Meal #5002, ad libitum, checked daily.
- Food analysis: No contaminants were detected.
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption, ad libitum, using an automatic watering system supplied by Edstrom Industries Inc.
- Water analysis: Conducted by Pennsylvania Gas and Water Company
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light, 12 hrs dark

Administration / exposure

Route of administration:

oral: gavage

Details on oral exposure:

VEHICLE
- Information not reported

MAXIMUM DOSE VOLUME APPLIED:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Potential route for human exposure

Doses:

Dose administration: 5000 mg/kg
Volume administration: 5 ml/kg

No. of animals per sex per dose:

5 females and 5 males

Details on study design:

- Frequency and duration administration: Once
- Length of the study: 15 days
- Frequency of observations and weighing: Weight and death body weights were recorded on Days -1, 1, 2, 3, 4, 7, 11.
- Necropsy of survivors performed: yes
- Other examinations performed: Twice daily rats were observed for clinical effects, CNS effects and mortality.

Statistics:

Not reported

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study

Clinical signs:

5 hrs after dosing: piloerection was observed in 7/10 rats
At Day 2: Diarrhea and piloerection, and decreased body were observed in 2 different rats.
At Day 3: Decreased body tone was observed in 1 rat.

Body weight:

No significant changes

Gross pathology:

No visible lesions

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

The estimated acute oral LD50 in rats for Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was determined to be greater than 5000 mg/kg.

Executive summary:

The study investigated the Acute oral toxicity of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers on female and male Sprague-Dawley rat. A single dose of 5000 mg/kg was administered orally by gavage and animals were observed for 14 days. No mortality occurred during the study and no visible lesions were recorded at necroscopic analysis. Piloerection and diarrhea were observed in 7 rats after dosing. After 2 days diarrhea and piloerection, and decreased body were observed in 2 different rats, while after 3 days decreased body tone was observed in 1 rat.

In conclusion, the acute oral toxicity in rats was determined to be greater than 5000 mg/kg.