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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study similar to OECD Guideline and subject to GLP audit

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute 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

Molecular formula:

C10H16 - C50H80

IUPAC Name:

Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers. “2,6,6-trimethylbicyclo[3.1.1]hept-2-ene, oligomers, consisting of mainly of dimers and trimers formed from the catalytic partial homo-polymerisation of 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene (also known as alpha-pinene)”,

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Perfection Breeders, Inc.
- Weight at study initiation: 2-3 kg
- Fasting period before study:
- Housing: Separate isolation by test system
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed.
- Food Analysis: Acute dose minimize the effect of contaminants. There were no contaminants.
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc.
- Water Analyses: Conducted by Pennsylvania Gas and Water Company
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C+/-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light-12 hrs dark

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk of animal, dorsal body surface area
- % coverage: 100%
- Type of wrap if used: Layer of gauze, rubber dam and an ace bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was wiped to remove any remaining material
- Time after start of exposure: After 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mg/kg
- Concentration (if solution):
- Constant volume or concentration used: yes

VEHICLE
- Information not reported

Duration of exposure:

24 hrs

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females and 5 males

Control animals:

not required

Details on study design:

- Duration of observation period following administration: Observation were recorderd at 10-20 minutes, 1-2 and 4-6 hrs after the 24 hrs period of exposure, and twice daily thereafter for fourteen days.
- Frequency of observations and weighing: Body weights were recorderd on Days: -1, 1, 2, 3, 4, 7, 11, 15.
- Gross necropsy of survivors performed: yes
- Other examinations performed: treated and untreated skin was preserved in 10% buffered formalin and retained for possible histopathological examinations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 other: mg/kg

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: Decreased body tone

Gross pathology:

No visible lesions

Any other information on results incl. tables

Erythema Score
Rabbit #	Day 1	Day 2	Day 3	Day 4	Day 7	Day 14
1	2	1	1	1	0	0
2	2	2	2	2	1	0
3	1	0	0	0	2	0
4	1	1	1	1	1	0
5	2	1	1	1	1	0
6	1	1	1	1	0	0
7	2	1	0	0	1	0
8	1	2	2	2	0	0
9	1	1	2	1	1	0
10	2	2	1	1	1	0
Edema score
Rabbit #	Day 1	Day 2	Day 3	Day 4	Day 7	Day 14
1	0	0	0	0	0	0
2	1	0	0	0	0	0
3	0	0	0	0	0	0
4	0	0	0	0	0	0
5	1	0	0	0	0	0
6	0	0	0	0	0	0
7	1	0	0	0	0	0
8	0	0	0	0	0	0
9	0	0	0	0	0	0
10	0	1	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

Based on the observations made in the acute dermal toxicity Test in Rabbit, the estimated acute Dermal LD50 for Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was determined to be greater than 2000 mg/kg.

Executive summary:

The study investigated the acute dermal toxicity of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers in 10 male and female rabbits. The test material was applied to about 240 cm of the dorsal body surface skin, which was previously shaved. The application was done direclty onto the exposed skin of the animals and a layer of gauze was wrapped around the animals to cover the dosed area. In addition, the animals were wrapped with rubber dam and an ace bandage to retard evaporation. The skin was exposed for 24 hrs and the animals were observed for 14 days. The results of the test showed that the acute dermal LD50 was greater than 2000 mg/kg.