2,2'-(C12-14 evennumbered alkyl imino) diethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 7 December 1983 and 7 January 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Rational for the reliabiliy: No data on composition. Basic data given; the method followed is comparable with OECD 425.

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)

GLP compliance:

not specified

Remarks:

in-house quality assurance was in place

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.

EC Number:

276-014-8

EC Name:

Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.

Cas Number:

71786-60-2

Molecular formula:

Not applicable

IUPAC Name:

2,2'-(C12-18 evennumbered alkyl imino) diethanol

Test material form:

liquid: viscous

Details on test material:

- Chemical name: Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.
- EC number: 276-014-8

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/CFY (remote Sprague-Dawley)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Limited, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 80 to 129 g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing
- Housing: individually housed in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum, Laboratory Diet No. 1, Spratt's Rodent Breeding Diet (LAD 1)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 45
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: Between 7 December 1983 and 7 January 1984

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
2.9 ml/kg

Doses:

1.0, 1.26, 1.6, 2.0, 2.5 g/kg

No. of animals per sex per dose:

The study continued until 6 animals per sex had been dosed after reversal of the initial outcome; 11 males and 11 females were
used in total.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: twice daily observations and individual bodyweights of rats were measured on Days 1 (day of dosing), 8 and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: none

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 determined by adding and subtracting 1.96 times the standarderror of the (log.) LD50 estimate.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 700 mg/kg bw

95% CL:

1 300 - 1 600

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

95% CL:

1 000 - 1 600

Mortality:

see: remarks on results including tables and figures

Clinical signs:

other: Signs in all rats after dosing included piloerection, hunched posture and abnormal gait (waddling). These signs were accompanied by: lethargy, decreased respiratory rate, ptosis and pallor of the extremities amongst rats at all the dose levels, increased

Gross pathology:

No effects observed in survivors. Autopsy of animals that died revealed congestion of the lungs and pallor of the liver, kidneys and spleen.

Any other information on results incl. tables

Mortality data

0 = survival

1 = death

		mortality data on each dosing occasion
sex	dose (g/kg)	1	2	3	4	5	6	7	8	9	10	11
m	1.0	0
m	1.26				0		0		0
m	1.6			1		1		1		0
m	2.0										1
m	2.5		1									1
f	1.0	0				0		0
f	1.26				1		0		0		1
f	1.6			1						1		1
f	2.0
f	2.5		1

Time and number of deaths

sex	dose (g/kg)	No. of deaths	Day
			1	2		3		4		5		6 -8
		No. Dosed	0.5 -6 h after dosing	a	b	a	b	a	b	a	b	a	b
m	1.0	0/1
m	1.26	0/3
m	1.6	3/4				2				1
m	2	1/1					1
m	2.5	2/2				2
f	1.0	0/3
f	1.26	2/4			1		1
f	1.6	3/3			1	2
f	2.5	1/1				1

a First observation

b Second observation

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute median lethal oral doses (LD50) in rats and their 95% confidence limits were estimated to be:
Males: 1.7 (1.3 to 2.1) g/kg bodyweight
Females: 1.3 (1.0 to 1.6) g/kq bodyweight

Executive summary:

The acute oral toxicity of the registration substance is derived based on the read-across approach.

The supporting substance CAS 71786 -60 -2 was tested for its acute oral toxicity.

Male and female rats were administered a single dose of the undiluted test compound ranging from 1.0 to 2.5 g/kg bw. Clinical signs in all rats after dosing included piloerection, hunched posture and abnormal gait (waddling). These signs were accompanied by lethargy, decreased respiratory rate, ptosis and pallor of the extremities amongst rats at all the dose levels, increased salivation amongst rats dosed at 1.0, 1.26, 1.6 and 2.5 g/kg, and diarrhoea in one female rat treated at 1.26 g/kg and one male at 1.6 g/kg. Recovery of survivors as judged by external appearance and behaviour was apparently complete 5 to 7 days after dosing. Body weight of the survivors was not affected, animals that died had decreased bodyweights. Necropsy findings were normal in survivors; in non-survivors these consisted of congestion of the lungs, and pllaor of the liver, kidneys and spleen. The acute median lethal oral doses (LD50) and their 95% confidence limits were estimated to be 1.7 (1.3 to 2.1) g/kg bw for males, and 1.3 (1.0 to 1.6) g/kq bw for females. According to these results the substance should be classified as Category IV according to OECD-GHS criteria.