Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
Decreased body tone
Body weight:
No changes
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.