Tall oil, sodium salt

Endpoint summary

Description of key information

The key study for acute oral toxicity is a study with the analogue substance Crude Tall Oil (CTO), which was conducted in accordance with OECD TG 423 (acute toxic class method) and in compliance with GLP. No treatment-related effects were observed and the LD50 was concluded to be >5000 mg/kg bw for male and female rats.

 

The key study for acute dermal toxicity is a study with the analogue substance Crude Tall Oil (CTO), which was conducted in accordance with OECD TG 402 and in compliance with GLP. No treatment-related effects were observed and the LD50 was concluded to be >2000 mg/kg bw for male and female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

15 days

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study was conducted according to a study protocol comparable to current guideline and in compliance with GLP. However, a limitation of the study was the lack of information on the purity of the test material.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Principles of method if other than guideline:

5 Male and 5 female SD rats were fasted overnight prior to receiving a single oral dose of 5.0 g/kg (bw) of the test article . They were then observed frequently on the day of dosing and daily for a total of 15 days. All gross and visible toxic or pharmacological effects were recorded.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

25g test material added to 50 ml corn oil

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Single oral dose of 5 g/kg (bw) - 25 g of test substance in 50 ml of corn oil as vehicle. Prepared physical state was described in the report as a "slurry".

No. of animals per sex per dose:

5 male and 5 female per dose.

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

In a well conducted LD50 oral study in rats (reliability 2), 5 g/kg (bw) was adminstered by gavage to a group of 5 male and 5 female SD rats and observed for a period of 15 days for signs of lethality and other overt effects. No treatment related effects were obersved and the LD50 was determined to be > 5000 mg/kg (bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was conducted accordign to a protocol comparable to current guideline and in compliance with GLP. However, a limitation of the study was that there was no information regarding the purity of the test substance.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The back and flanks of 5 male and 5 female adult New Zealand White rabbits were clipped free of fur (ca 10% of total body surface), not more than 24 hours prior to study initiation. The skin was abraded (minor incisions through the stratum corneum) on 3 males and 2 females prior to dosing. 2g/kg (bw) of the test material was administered under an occlusive binding.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2 g/kg (bw) adminstered dermally.

No. of animals per sex per dose:

5

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One animal died during the study, but this was due to enteropathy, and was not substance related.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

In a well conducted acute dermal study (reliability 2), white New Zealand Albino Rabbits were dosed 2g/kg (bw). No substance related effects were reported why the LD50 was determined to be >2000 mg/kg (bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

No acute inhalation toxicity data are available for the registration substance or relevant read-across substances. Since the substance is non-volatile and reliable acute oral and dermal toxicity data are available for the analogue substance (Distilled Tall Oil or Crude Tall Oil), no further testing for the inhalation route is required.

Supporting data for the related substance ‘plant sterols’ are included in support of the weight of evidence approach for long-term toxicity endpoints. Additional information on the test material composition is available in Section 5.6.3. In an acute oral toxicity study (FDRL,1982b), conducted using EPA OPPTS 870.1100 and in compliance with GLP, 5 g/kg (bw) of plant sterols was administered by gavage to 5 male and 5 female SD rats. Thereafter, observation continued for a period of 15 days for signs of lethality and other overt effects. No treatment related effects were observed and the LD50 was determined to be >5 g/kg (bw).

In an acute dermal study (FDRL, 1982a), conducted to OECD 402 and in compliance with GLP, white New Zealand Albino Rabbits were dosed with 2 g/kg (bw) plant sterols. No substance related effects were reported and the LD50 was determined to be >2000 mg/kg (bw).

Justification for classification or non-classification

Based on the available read-across data, TOS does not require classification for acute toxicity according to Regulation (EC) No 1272/2008.