2,2'-(octadec-9-enylimino)bisethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November-December 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Complete report according to guidelines/standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(octadec-9-enylimino)bisethanol

EC Number:

246-807-3

EC Name:

2,2'-(octadec-9-enylimino)bisethanol

Cas Number:

25307-17-9

Molecular formula:

C22H45NO2

IUPAC Name:

2,2'-(Octadec-9-enylimino)bisethanol

Test material form:

liquid

Details on test material:

Chemical name: Bis(2-hydroxyethyl)oleylamine
CAS number: 25307-17-9

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna (UK) Ltd., Wyton, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 123-152 g (males), 120-146 g (females)
- Fasting period before study: overnight prior to dosing until ca. 2 hours after dosing
- Housing: 5/sex in solid floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-65
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 7 November To: 10 December 1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: neat test compound was used

MAXIMUM DOSE VOLUME APPLIED: 2.20 ml/kg bw

Doses:

1000, 1260, 1587, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made 1 and 4 h after dosing and once daily thereafter. BW were
measured weekly and at death
- Necropsy of survivors performed: yes

Statistics:

Method of Weil CS, Biometrics (1952), 8, 249

Results and discussion

Preliminary study:

A preliminary study was carried out using 2 groups of one male and one female each. Dose levels were 500 and 2000 mg/kg bw.
At 500 mg/kg the 2 animals survived, whereas both animals died at 2000 mg/kg bw.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 260 mg/kg bw

95% CL:

1 053 - 1 508

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 309 mg/kg bw

95% CL:

1 024 - 1 674

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 587 mg/kg bw

Mortality:

All deaths occurred 2-3 days after treatment.

Clinical signs:

other: Major signs of toxicity noted in all dose groups during the day of dosing were hunched posture, pilo-erection, decreased respiratoryrate, increased salivation and ptosis. Surviving animals treated with 1000 mg/kg continued to show signs of toxicity on day

Gross pathology:

Common abnormalities noted at necropsy of decedents were congested or abnormally red lungs, dark livers, haemorrhage of the
gastric mucosa and congestion of the small intestines. Necropsy of animals killed at the end of the study revealed scattered
white thickened or raised areas on the non-glandular region of the stomach. The liver of two animals treated with 2000 mg/kg was adhering to the stomach. One decedent treated with 1000 mg/kg and two animals treated with 1587 mg/kg were cannabalised. No
necropsy was performed.

Other findings:

No data

Any other information on results incl. tables

Mortality data

Dose level (mg/kg bw)	Deaths
	Male	Female	Total	%
1000	0/5	1/5	1/10	10
1260	3/5	3/5	6/10	60
1587	4/5	4/5	8/10	80
2000	3/5	4/5	7/10	70

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The LD50 value was calculated to be 1260 mg/kg bw with 95% confidence limits of 1053 and 1508 mg/kg bw. The test compound was classied in Category IV according to OECD-GHS.

Executive summary:

A study was performed to determine the acute oral toxicity of the test material in the Sprague-Dawley CFY strain rat. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity". Following a range-finding study, four groups, each of ten fasted animals (five males and five females) were given a single oral dose of undiluted test material, at dose levels of 1000 to 2000 mg/kg bodyweight. Deaths were noted two to three days after treatment. Major signs of toxicity noted during the day of dosing were hunched posture, pilo-erection, lethargy , decreased respiratory rate, increased salivation and ptosis. Less frequent signs of ataxia, pallor of the extremities, diarrhoea, diuresis, chromodacryorrhoea, tiptoe gait, emaciation, red/brown staining around the snout/eyes were also noted. Signs of reaction continued to be noted up to three to fourteen days after treatment. Surviving animals treated with 1000 mg/kg showed expected body weight gains over the study period. Effects on body weight were noted in other dose groups during the first week but all animals recovered to show expected body weight gains over the second week. Necropsy of decedents revealed congested or abnormally red lungs, dark livers , haemorrhage of the gastric mucosa with congestion of the small intestines. Necropsy of animals killed at the end of the study revealed thickened or raised white areas on the non-glandular region of the stomach. The acute oral median lethal dose (LDS0) and 95% confidence limits were found to be:

All animals: 1260 (1053 - 1508) mg/kg body weight

Males only: 1309 (1024 - 1674) mg/kg body weight

Females only: between 1000 and 1587 mg/kg body weight (best estimate).