Oligomerisation products of beta-pinene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 81-2 (Acute Dermal 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

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 2.3 - 2.7 kg (for both males and females)
- Housing: Animals were housed 1 per cage in suspended wire mesh cages. Bedding was placed under each cage and changed twice a week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) provided daily
- Water: ad libitum
- Acclimation period: 1 week

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

24 hours prior to the application of the test substance, the dorsal area of each animal was clipped free of hair. The clipped area was approximately 10% of the body surface and remained intact.

The test substance was used as received and applied to the prepared dermal site by a syringe applicator at a dose of 2000 mg/kg. The treated site was covered with a gauze patch (applied with pressure to evenly distribute test substance) and secured with non-irritating tape. Patches were removed at 24 hours and any residual test substance was washed off with distilled water. Dermal observations were performed.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

10 animals (5 males, 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1, 2 and 4 hours post exposure of the test substance and then once daily for 14 days. Animals were observed twice daily for mortality. Animal bodyweights were recorded prior to the test, weekly and at death or termination.
- Necropsy of survivors performed: All animals were examined for gross pathology, Abnormal tissues were kept in 10% formalin for possible future microscopic examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed during this study

Clinical signs:

other: Lack of faecal production was noted in one animal.

Gross pathology:

Necropsy results were normal in 3/10 animals. The remaining studies exhibited skin abnormalities, one of which also showed kidney abnormalities (pitted kidneys).

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 dermal LD50 in rabbits was determined to be >2000 mg/kg.

Categories Display