Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 17, 1988 to April 03, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl)

EC Number:

931-330-1

IUPAC Name:

Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl)

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Bor:WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Average weight at study initiation: 119 g
- Housing: Macrolon type III cages, 1-5 animals/cage
- Diet (e.g. ad libitum): R10 diet for rats, Ssniff special feed, 4770 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 4 - 8 d
- Fasting period before test begin: 16 h

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% test substance in corn oil
- Amount of vehicle (if gavage): 15 cm3/kg bw

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 days
- Frequency of observations and weighing: pre-dose, Days 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: None.

Gross pathology:

No effect of the test substance.

Any other information on results incl. tables

Table 1: Bodyweight evolution (average weight) in g

Dose (mg/kg bw)	Pre-dose (fasted)	24 h	Week 1	Week 2	Bodyweight gain
3000	119.0	127.1	160.6	190.2	71.9

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 was determined to be >3000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C8-18 and C18-unsatd. MEA, to Bor:WISW (SPF TNO) rats according to OECD Guideline 401. Male and female rats were gavaged once with the test substance in corn oil at 3000 mg/kg bw and observed during 14 d for clinical signs, mortality and bodyweight evolution. Gross pathology was conducted on all animals at termination. There were no clinical signs and no mortality during the study. Bodyweight evolution remained within expected values. No macroscopic changes in the organs were observed at test end. Under the study conditions, the LD50 was determined to be >3000 mg/kg bw (Mürmann, 1988).