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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 August 2005 - 7 September 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Justification for read across, see attached document.

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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001 and the Directive 2004/73/EC, method B.1 tris.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

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:
other: Crl:CD(SD)IGS BR.
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
300 (mg/kg b.w.) and 2000 (mg/kg b.w.)
No. of animals per sex per dose:
3 per step (6 per dose)
Control animals:
no

Results and discussion

Preliminary study:
As no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50, oral > 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 peroral administration to rats.

Methods

Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001 and the Directive 2004/73/EC, method B.1 tris.

Administration of the test substance

"CRUDE TALL OIL" was administered once as a solution in corn oil, given orally via gavage to female Crl:CD(SD)IGS BR rats.

The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose.

The dose volume was 10 mL per kg body weight for all groups.

Investigations

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

• Clinical observations: at least once per day.

• Necropsy: The animals were sacrificed and necropsied 14 days p.a.

Results

According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for acute oral toxicity.