Fatty acids, tall-oil, magnesium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 August 2005 - 25 August 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for read-across, see attached file.

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)

Version / remarks:

OECD-Guideline 402, 1987

GLP compliance:

yes (incl. QA statement)

Test type:

other:

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

Molecular formula:

Not applicable - UVCB substance

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: A cellulose patch with the individually weighed amount of the test substance on the surfac

Duration of exposure:

24h

Doses:

The dose was 2000 mg per kg body weight.

No. of animals per sex per dose:

5 male and 5 female/dose

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

other: LD50 dermal

Effect level:

> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50, dermal > 2000 mg /kg body weight

Executive summary:

Aim of the study

The aim of the study was to investigate acute toxic effects of the test substance after a single dermal administration to rats.

Methods

Methods and investigations were performed in conformance with the OECD-Guideline 402, 1987 and the Directive 92/69/EEC, annex B.3.

Administration of the test substance

"CRUDE TALL OIL", was administered once dermally on an area of approximately 6.5 cm x 8 cm on the dorsal thoracal region of 5 male and 5 female Sprague Dawley rats.  The dose was 2000 mg per kg body weight.

A cellulose patch with the individually weighed amount of the test substance on the surface, was applied to the test site and held in place by fixing marginally with non irritating tape.

Patch and tape were covered semi-occlusively by a dressing.

The duration of the exposure was 24 hours.

Investigations

• Body weights: before the administration, 7 and 14 days after the administration (p.a.).

• Clinical observations: at least once per day.

• Necropsy: 14 days p.a.

Results

presence of clinical signs: 

• no signs

full recovery of the survivors:

• not applicable

body weights:

• inconspicuous in all males 0 - 14 d p.a.
• body weight loss in one female 0 - 7 d p.a.  
• inconspicuous in all females 7 - 14 p.a. sex differences no

findings in life and post-mortem indicate:

• no toxic effects present

LD50, dermal > 2000 mg /kg body weight

 

Conclusion

No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem-examination at a dose of 2000 mg of the test substance per kg body weight.

No mortality occurred.

No classification of "CRUDE TALL OIL" is therefore derived from the results of this study according to the Directive 93/21/EEC.