Fatty acids, tall-oil, low-boiling

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

09.08.05 to 12.10.05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP using a related test substance.

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 (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tall oil

EC Number:

232-304-6

EC Name:

Tall oil

Cas Number:

8002-26-4

IUPAC Name:

8002-26-4

Details on test material:

- Name of test material (as cited in study report): Crude Tall Oil
- Substance type: Complex mixture
- Physical state: Brown liquid
- Analytical purity: No data
- Composition of test material, percentage of components: Complex mixture
- Purity test date: No data
- Lot/batch No.: 2005-06-09, sample 4.
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature, in the dark.

Test animals

Species:

rat

Strain:

other: CRL: CD(SD)BR SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: Males: 8 weeks. Females: 12 weeks.
- Weight at study initiation: Males: 270 - 284 g. Females: 245 - 252g.
- Fasting period before study: No
- Housing: Individually in Makrolon cages Type III
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (average)
- Humidity (%): 67 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 09.08.05 To: 25.08.05

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 52 cm2
- % coverage: 10% of estimated body surface.
- Type of wrap if used: Cellulose patch was held in place by a non-irritating tape. The patch and tape were covered semi-occlusively by a dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with wet cellulose tissue.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 0-0.5, 0.5-1, 1-2, 2-4 and 4-6 hours after administration of the test substance and then at least once per day for two weeks. Body weights were recorded before administration and on Days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths occurred

Mortality:

All animals survived until scheduled termination of the study.

Clinical signs:

There were no clinical signs of toxicity.

Body weight:

Body weight loss was noted in 1/5 females in the first week. The authors concluded that this might have been caused by the discomfort of the dressing and was not considered to be toxicologically significant. Body weights and body weight gains were normal in the second week. There were no effects on male body weights.

Gross pathology:

There were no abnormal findings during the gross pathological examination.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a good quality acute dermal toxicity study (reliability score 1) conducted to OECD test guideline 402, and GLP, the LD50 for Crude Tall Oil was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats.

Executive summary:

A single dermal administration of Crude Tall Oil was performed, by spreading the test substance on an area of skin that was at least 10% of the estimated body surface of male and female CRL: CD(SD)BR SPF rats. 2000 mg/kg bw of the test substance was held in place with a semi-occlusive dressing for 24 hours. At the end of the exposure period the residual test substance was wiped off with a wet cellulose tissue, when necessary. The animals were then observed for 14 days. Clinical observations were noted at least once per day, body weights were recorded before administration, and on days 7 and 14. At the end of the observation period all animals were sacrificed and necropsied. There were no clinical signs of toxicity, no deaths and there were no treatment-related effects on body weight. The dermal LD₅₀ was therefore greater than 2000 mg/kg bw.