Fatty acids, tall-oil, compds. with diethanolamine

Endpoint summary

Description of key information

Oral

A study was performed to assess the acute oral toxicity of the test substance, C16-18 and C18-unsatd. DEA, in Bor: WISW rats according to OECD Guideline 401. A group of 20 fasted animals (10 males and 10 females) were given a single oral dose of 3000 mg/kg bw undiluted test substance. The animals were observed for 14 d then sacrificed and subjected to gross pathological examination. There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals. Under the study conditions, the LD50 of the test substance in rats was found to be >3000 mg/kg bw(Mürmann, 1990).

Dermal

A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).

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:

key study

Study period:

From December 12, 1989 to February 14, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Bor:WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Weight at study initiation: 249 g
- Fasting period before study: > 16 h
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: R10 Alleindiät for rats, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5-8 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 60 +/- 5%
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 3.09 cm3/kg

Doses:

3000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of clinical observation: Continuously up to 6 h post-treatment and subsequently once daily for 14 d
- Frequency of weighing: Pre-treatment , then on Days 1, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: All animals were in resting position 30 minutes after dosing. Three had slightly rough fur. Thirty minutes later, no symptoms were seen anymore.

Gross pathology:

Six animals showed local thickenings of the mucous membrane of the forestomach; in three of these animals, the mucous membrane of the stomach was slightly reddened.

Other findings:

None.

None.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 of the test substance in rats was found to be >3000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the test substance, C16-18 and C18-unsatd. DEA, in Bor: WISW rats according to OECD Guideline 401. A group of 20 fasted animals (10 males and 10 females) were given a single oral dose of 3000 mg/kg bw undiluted test substance. The animals were observed for 14 d then sacrificed and subjected to gross pathological examination. There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals. Under the study conditions, the LD50 of the test substance in rats was found to be >3000 mg/kg bw (Mürmann, 1990).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 000 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:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Refer to the section 13 for details on the category justification.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: A modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Weight at study initiation: 1.9-2.7 kg

No further information avaialble.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the 24 h exposure period the sleeve was removed and the skin sites gently cleansed.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Details on study design:

All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities observed.

Clinical signs:

other: All animals appeared normal through Day 14.

Gross pathology:

Not evaluated.

Other findings:

Not evaluated.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute dermal LD50 in rabbits was found to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The available data for C16-18 and C18-unsatd. DEA and the read across substance C8 -18 and C18 -unsatd. DEA indicate a low potential for acute toxicity (oral and dermal LD50 of >3000 and >2000 mg/kg bw, respectively). Therefore, the test substance does not warrant classification for acute toxicity according to EU CLP (EC 1272/2008) criteria.