2,2',2''-nitrilotriethanol

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study which meets basic scientific principles

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2',2''-nitrilotriethanol

EC Number:

203-049-8

EC Name:

2,2',2''-nitrilotriethanol

Cas Number:

102-71-6

Molecular formula:

C6H15NO3

IUPAC Name:

2-[bis(2-hydroxyethyl)amino]ethan-1-ol

Test animals

Species:

rat

Strain:

other: Cox CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

20 male and 20 female per group
Diet: ad libitum

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: standard chow

Duration of treatment / exposure:

91 days

Frequency of treatment:

continuously

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

250 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

500 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

1 000 mg/kg bw/day (nominal)

No. of animals per sex per dose:

20

Control animals:

yes, concurrent no treatment

Details on study design:

Post-exposure period: no

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
FOOD EFFICIENCY: Yes
HISTOPATHOLOGY: Yes
HAEMATOLOGY: Yes

Sacrifice and pathology:

HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:

effects observed, non-treatment-related

Description (incidence and severity):

One rat escaped from its cage during the third week of the test and had to be eliminated because of contamination. One male from the mid-dose group and one female from the low-dose group displayed symptoms of inner ear infection.

Haematological findings:

effects observed, non-treatment-related

Description (incidence and severity):

The only abnormality observed was a slightly elevated WBC in one animal. This change was not considered significant. All other values are within normal limits and there were no significant differences between treatment groups.

Organ weight findings including organ / body weight ratios:

no effects observed

Description (incidence and severity):

There were no significant differences notes in organ to body weight ratios.

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

effects observed, non-treatment-related

Description (incidence and severity):

No lesions were found which followed a pattern of agent-induced toxicity. Tissue alterations observed were mild and were not considered significant.

Details on results:

AVERAGE BODY WEIGHT GAIN, FEED CONSUMPTION, AND EFFICIENCY
The only adverse significant differences noted were in body weight gain and feed efficiency in the female rats of the mid-dose group.

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: no significant effects at highest dose tested

Target system / organ toxicity

Key result

Critical effects observed:

not specified

Any other information on results incl. tables

Bodyweight gain

	males	females
Control	341±30	157±23
TEA-1 (250 mg/kg)	339±35	170±13
TEA-1 (500 mg/kg)	331±28	151±15
TEA-1 (1000 mg/kg)	329±32	161±22

 

Feed consumption

	males	females
Control	2143±155	1542±105
TEA-1 (250 mg/kg)	2073±165	1592±108
TEA-1 (500 mg/kg)	2076±282	5166±115
TEA-1 (1000 mg/kg)	2091±155	1604±123

 

Feed efficiency

	males	females
Control	15.95±0.98	10.18±1.1
TEA-1 (250 mg/kg)	16.35±0.97	10.72±0.67
TEA-1 (500 mg/kg)	15.56±0.84	8.62±2.7
TEA-1 (1000 mg/kg)	15.75±0.99	9.99±0.88

   

Organ to bodyweight ratio (LIVER)

	males	females
Control	38.2±3.3	42.1±12.2
TEA-1 (250 mg/kg)	41.6±3.7	39.9±3.3
TEA-1 (500 mg/kg)	45.9±6.9	44.6±1.0
TEA-1 (1000 mg/kg)	49.6±2.9	45.3±2.9

 

Organ to bodyweight ratio (KIDNEY)

	males	females
Control	7.6±0.6	8.1±0.3
TEA-1 (250 mg/kg)	9.3±1.3	10.2±1.4
TEA-1 (500 mg/kg)	9.2±0.7	11.1±0.7
TEA-1 (1000 mg/kg)	10.4±1.4	10.3±1.4