Oligomerisation products of beta-pinene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nu-Film-P

IUPAC Name:

Nu-Film-P

Constituent 2

Reference substance name:

Oligomerisation products of beta-pinene

EC Number:

701-246-8

Molecular formula:

Variable (dimer = C20-H34)

IUPAC Name:

Oligomerisation products of beta-pinene

Details on test material:

Typical pinene oligomers content 96 wt%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: Males, 201 - 226 g; females, 206 - 223 g
- Housing: Housed 5/sex/cage in suspended wire mesh cages. Bedding was placed under cages and changed twice a week.
- Diet: Fresh Purina Rat Chow (Diet #5012) ad libitum
- Water: ad libitum
- Acclimation period: 1 week

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test substance was used as received and was adminstered by oral gavage using a syring and dosing needle.

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 animals (5 male and 5 female)

Control animals:

no

Details on study design:

All animals were observed at 1, 2 and 4 hours post oral administration and then once daily for 14 days for signs of toxicity. All animals were observed twice a day for mortality. Body weights were recorded prior to the test, weekly and at death or termination in survivors.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during this study

Clinical signs:

other: The only clinical signs observed were wet, brown stained anogenital areas in 3 rats (1 male, 2 female) during days 1-4.

Gross pathology:

Necropsy results were normal

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under the conditions of this study, the LD50 in rats was determined to be >5000 mg/kg. It is reasonable to assume that pinolene will produce a similar result.