Ethanol, 2,2'-iminobis-, N-(C16-18 and C18-unsatd. alkyl) derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January-February 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given; comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Principles of method if other than guideline:

At the time of performance, OECD 425 was not available.

GLP compliance:

yes

Remarks:

in house quality system

Test type:

up-and-down procedure

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol

EC Number:

620-540-6

Cas Number:

1218787-32-6

Molecular formula:

No molecular formula

IUPAC Name:

2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol

Test material form:

other: waxy soliod

Details on test material:

- Chemical name: 2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol
- EC number: 620-540-6

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: HC/HFY (remote Sprague-Dawley)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Ltd., Huntingdon, UK
- Age at study initiation: ca. 4-6 weeks
- Weight at study initiation: 81-132 g
- Fasting period before study: overnight prior to dosing until ca. 4 hours after dosing
- Housing: individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): mean 42
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 10 January To: 13 February 1984

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE: methyl celluose (1%)
- Concentration in vehicle: various concentrations in vehicle to obtain dose volumes of 10.0 ml/kg


MAXIMUM DOSE VOLUME APPLIED: 10.0 ml/kg bw

Doses:

800, 1000, 1260, 1600, 2000, 2500, 4000, 5000 mg/kg bw

No. of animals per sex per dose:

1 at each dose level in time (11 males and 12 females in total)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:soon after dosing, frequently on the remainder of the day of dosing. At least twice per
day thereafter. BW were monitored on day 0 and day and at death.
- Necropsy of survivors performed: yes

Statistics:

LD50 values were estimated by probit analysis, using a slope estimated from background data. The probit model was fitted by
maximum likelihood, with a slope of 8.333 (equivalent to a standard deviation of 0.12 units for the distribution of individual (log.)
tolerance levels). Approximate confidence intervals (95% level) were derived by adding and subtracting 1.96 times the standard
error of the (log.) LD50 estimate.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 500 mg/kg bw

95% CL:

1 100 - 2 000

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

95% CL:

900 - 1 600

Mortality:

Deaths occurred amongst rats treated at 1.26 g/kg and above from within two and three days of dosing. Autopsy revealed
haemorrhage or congestion of the lungs in the majority of animals. These findings were usually accompanied by pallor of the liver,
kidneys and spleen. Congestion of the blood vessels of the stomach was observed in one female rat treated at 1.6 g/kg and
congestion of the blood vessels of the intestine in one female rat treated at 5.0 g/kg. All rats that died showed a bodyweight loss.

Clinical signs:

other: Signs of reaction to treatment observed shortly after dosing in all rats included pilo-erection and abnormal body carriage (hunched posture). Abnormal gait (waddling), lethargy and pallor of the extremities were observed in the majority of rats in all tre

Gross pathology:

Necropsy findings in survivors were normal.

Other findings:

No data.

Any other information on results incl. tables

Mortality data

Sex	Dose (mg/kg)	Mortality data on each occasion												No. of deaths
		1	2	3	4	5	6	7	8	9	10	11	12
M	1000	0								0				0/2
	1260								0		0	0		0/3
	1600					1		1						2/2
	2000						1							1/1
	2500				1									1/1
	4000			1										1/1
	5000		1											1/1
F	800											0		0/1
	1000	0									0		0	0/3
	1260									1				1/1
	1600					1		1						2/2
	2000						1		1					2/2
	2500				1									1/1
	4000			1										1/1
	5000		1											1/1

0 = animal survived; 1 animal died

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The LD50 values (plus 95% confidence limits) were 1500 (1100-2000) mg/kg bw for males, and 1200 (900-1600) mg/kg bw for
females. The test compound was therefore classified in Category IV according to OECD-GHS.

Executive summary:

The study was performed to assess the acute toxicity of the test material following a single oral administration to the HC/CFY (remote Sprague-Dawley) strain rat. The study was performed equivalent to OECD 425. A group of 11 fasted males and 12 fasted female was given a single, oral dose of the test material at dose levels between 800 and 5000 mg/kg bodyweight. The animals were observed for 7 days after the day of dosing and were then killed for gross pathological examination. Deaths were observed at levels 1260 mg/kg bw and higher. Clinical signs of toxicity noted were pilo-erection, hunched posture, abnormal gait, lethargy, pallor of the extremities, ptosis, diarrhoea, increased salivation, and decreased respiratory rate. Recovery was apparently complete by day 5 -8 (day 1 is day of dosing). All surviving animals showed expected gains in bodyweight over the study period. No abnormalities were noted in survivors at necropsy. Non-survivors generally showed haemorrhage or congestion of the lungs, and pallor of the liver, kidneys and spleen. The acute median lethal dose (LD50) of the test material (with 95% confidence limits) was found to be 1500 (1100 -2000) mg/kg bw in males, and 1200 (900 -1600) mg/kg bw in females. The test compound was therefore classified in Category IV according to OECD-GHS.