N,N-bis(2-hydroxyethyl)dodecanamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 8, 1985 to October 23, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

931-329-6

IUPAC Name:

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

Constituent 2

Reference substance name:

2,2'-iminodiethanol

EC Number:

203-868-0

EC Name:

2,2'-iminodiethanol

Cas Number:

111-42-2

Molecular formula:

C4H11NO2

IUPAC Name:

2,2’-iminodiethanol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding Centre Ltd, Ejby, DK-4623 LI. Skensved.
- Weight at study initiation: 148±3 g
- Fasting period before study: 18 h
- Housing: Housed in Macrolone cages Type III (42x26x15 cm) in groups of 2 or 3 per cage (males and females separated)
- Diet: Complete rodent diet - Altromin 1314, ad libitum
- Water: Drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: No acclimatization as the rats were born in the laboratory and had been kept in the same environment during the experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2
- Humidity (%): 55±15
- Air changes (per h): 10
- Photoperiod: 6-18 h of light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Maximum dose volume applied: 5 mL/kg

Rationale for the selection of the starting dose: A range-finding study was conducted, which indicated that LD50 would exceed 5000 mg/kg (details not reported)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of clinical observations: 1, 3 and 6 h after administration and daily thereafter once or twice for 14 d
- Frequency of weighing: Day 0, 7 and 14
- Necropsy of survivors performed: Yes

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: Sedation and piloerection were observed in all the rats shortly after treatment. All rats recovered completely by Day 2, except for one female, which showed pilorection till Day 7. This rat also showed pinched abdomen on Days 4, 5 and 6.

Gross pathology:

No macroscopic organ changes were observed, except for one rat (same animal which showed low body weight gain), in which the kidneys were presented with enlarged size, plumpy shape and light and pale tissue on macroscopic observation.

Other findings:

None.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 in rats was >5000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the test substance, C8-18 and C18-unsatd. DEA, in Wistar rats according to OECD Guideline 401. A group of 10 fasted animals (five males and five females) was given a single oral dose of test substance at a dose level of 5000 mg/kg bw. The animals were observed for 14 d after dosing, then sacrificed and subjected to gross pathological examination. Clinical signs such as sedation and piloerection were observed in all animals following gavage, with recovery by Day 2. There were no macroscopic changes in the organs at necropsy. No mortality was recorded in either sex. Under the study conditions, the LD50 in rats was >5000 mg/kg bw (Skydsgaard, 1985).