Fatty acids, tall-oil, magnesium salts

Endpoint summary

Description of key information

The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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.

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

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR.

Sex:

female

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

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.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

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.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Species:

rat

Strain:

other: US-rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 228 ± 22 (male), 161 ± 18 (female)

ENVIRONMENTAL CONDITIONS
not reported

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion containing 0.5 %Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2; 20; 30 %
- Amount of vehicle (if gavage): 1.2 - 3.4 ml depending on the body weight and dose group
MAXIMUM DOSE VOLUME APPLIED: 3,4 ml

Doses:

4.0, 3.2, 1.6 0.2 ml/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the except on weekends and on Holydays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 640 mg/kg bw

Mortality:

4.0 mL/kg: 0/10 died within 24 hrs; 5/10 animals died within 48 hrs; no additional death until study termination at day 7
3.2 mL/kg: 2/10 animals died within 24 hrs, 1 additional animal died after 48 hours; , no additional death until study termination at day 7
1.6 mL/kg: 1/10 animal died after 24 hrs, no additional death until study termination at day 7
0.2 mL: 0/10 wit in 7 days
4ml/kg of pure substance is equal to 3640 mg/kg bw (density 0.91 g/mL)

Clinical signs:

3.2 and 4 mL/kg: apathy, dyspnea, abdominal position,red crusted eyes and snouts. free of clinical signs by day 5
0.2 and 1.6 mL/kg: accelerated breathing; high steppy gait, ruffled fur. free of clinical signs by day 2

Body weight:

not recorded

Gross pathology:

No substance related findings were noted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

2 000 mg/kg bw

Quality of whole database:

Studies have been carried out according GLP and the recommended OECD guideline

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

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.

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

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

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

Key result

Sex:

male/female

Dose descriptor:

other: LD50 dermal

Effect level:

> 2 000 mg/kg bw

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.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF
- Age at study initiation: 7 weeks (males) 9 weeks (females
- Weight at study initiation: 208 +/- 4 g (males); 191 +/- 3 g (females
- Fasting period before study: no
- Housing: single in macrolone cages (Type 3) on wooden bedding
- Diet (e.g. ad libitum): ad libitum Altromin 1234 (Altromin GmbH, Lage/Lippe)
- Water (e.g. ad libitum): tab water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage:
- Type of wrap if used: alu folie, fixed by tape (Fixomull; Elastoplast; Fa. Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml pure substance (desity 0.9 g/ml)

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation : daily; weighing prior to application on day 7 and day 17 (Study termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not necessary

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality

Clinical signs:

no clinical symptoms besides eshar formation in two females from day 5-day 8

Body weight:

Body weight development was positive

Gross pathology:

no substance related macroscopic findings

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

2 000 mg/kg bw

Quality of whole database:

Studies have been carried out according GLP and the recommended OECD guideline

Additional information

Based on the available information, the acute toxicity of the Substance is low for two routes of administration. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.

Justification for selection of acute toxicity – oral endpoint: OECD & EC guideline study, no deviations, GLP  

Justification for selection of acute toxicity – dermal endpoint: OECD & EC guideline study, GLP

Justification for classification or non-classification

According to the study results on crude tall oil and 2 -ethylhexanoic acid the substance requires no clasification, because the results are not sufficient for classification.