Tall-oil pitch

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005/10/05-2005/10/19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tall-oil pitch

EC Number:

232-414-4

EC Name:

Tall-oil pitch

Cas Number:

8016-81-7

Molecular formula:

UVCB substance molecular formula unknown

IUPAC Name:

8016-81-7

Details on test material:

- Name of test material (as cited in study report): TALL OIL PITCH

- Physical state: Dark liquid

- Expiration date of the lot/batch: not stated

- Storage condition of test material: 10C-25C, in the dark

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 Deutschland GmbH, D-97633 Sulzfeld.

- Age at study initiation: ca. 8 weeks (males) and 12 weeks (females) at the time of administration

- Weight at study initiation: mean 237g (females), 267g (males)

- Fasting period before study: no mention

- Housing: Single caging in Makrolon cages type 3 (39x23x18cm). Wire mesh lids. Sanitation of cages once a week.

- Diet: Altromin 1324 forte (Altromin GmbH, D-32791 Lage)

- Water: Tap water from an automatic watering system, ad libitum

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): average of 22C

- Humidity (%): 55

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE

- Area of exposure: dorsal thoracal region, clipped free of hair

- % coverage: 10% of estimated body surface, an area of 6.5 x 8 cm (52 cm2)

- Type of wrap if used: A cellulose patch with the individually weighed amount of the test substance on the surface an held in place by fixing marginally with non irritating tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): At the end of the exposure period the dressing, the tape and the patch were removed. Residual test substance was wiped off using wet cellulose tissue, if necessary.

- Time after start of exposure: 24 hours


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): The amounts of the test substance were calculated and weighed for each individual using the body weights determined on the day of administration.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5M, 5F

Control animals:

other: The untreated skin surrounding the test area served as a negative control.

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Body weights were recorded before administration, and on days 7 and 14.. General signs of toxicity were taken once daily.

- Necropsy of survivors performed: On day 14.

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions. No skin examination of the administration site was possible during the exposure period, while it was covered by the patch and wrappings.

Statistics:

None reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs. All animals were normal during the observation period.

Gross pathology:

No toxic effects present.

Other findings:

- Other observations: Staining of the skin which was attributed to the staining property of the test substance was observed in all animals. No sex specific differences were observed.

Any other information on results incl. tables

No local or systemic toxic effects related to administration of test substance were noted from clinical observations or post mortem examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

An acute dermal LD50 value of >2000 mg/kg was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.