N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies. This reference does not provide a full report with regard to the methods used in this study. Although basic key information is reported the study does not follow the current testing guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Female Wistar rats were exposed to a saturated vapour of the test material for periods of 2h 10m or 4h 20m and observed for 14 days.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

EC Number:

234-205-3

EC Name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Cas Number:

10595-60-5

Molecular formula:

C16H33N3

IUPAC Name:

N-(1,3-dimethylbutylidene)-N'-{2-[(1,3-dimethylbutylidene)amino]ethyl}ethane-1,2-diamine

Test material form:

other: watery liquid

Details on test material:

- Physical details: light amber, watery liquid with a highly noticeable odour.
- Storage conditions: ambient room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 to 226 g
- Diet (e.g. ad libitum): ad libitum Wayne diet
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Details on inhalation exposure:

The animals were introduced into the exposure chamber simultaneously with 200 g of the test material and allowed to inhale the saturated vapour.
The test material was agitated by means of a magnetic stirrer bar at approximately 60 rpm during the exposure to facilitate the evolution of saturated vapour.
The capacity of the exposure chamber was 120 litres.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

2.2 - 4.3 h

Concentrations:

Saturated vapour

No. of animals per sex per dose:

6 animals were exposed for 2.2 hours.
6 animals were exposed for 4.3 hours.

Control animals:

not specified

Details on study design:

The temperature during the 130 minute exposure period was 24.2 °C; the temperature during the 260 minute exposure period was 23.3 °C.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and bodyweight

Statistics:

Lt50 is calculated by probit transformation based on 14 days’ observation.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

other: Lt50

Effect level:

3.1 other: hours

Based on:

test mat.

95% CL:

2.4 - 3.9

Mortality:

All rats exposed to the saturated vapour for 4h 20m died.
No animals in the 2h 10m exposure group died.

Clinical signs:

other: The 4h 20m (denoted above as 4.3h) exposure resulted in severe coordination loss, breathing difficulties and involuntary severe spasms of extremities. Eye irritation was also seen; reddening with excessive clear exudate. The 2h 10m (denoted above as 2.

Body weight:

Weight changes for the surviving animals were considered to be below normal. Animals in the 2h 10m (denoted above as 2.2h) exposure group gained between 8 and 32 g, with a mean weight gain of 22.5g.

Gross pathology:

Necropsy on the 6 deceased animals from the 4h 20m (denoted above as 4.3h) exposure group revealed severe lung congestion and haemorrhage, and darkened and/or mottled liver surfaces in all animals. Furthermore, full urinary bladders were seen in all 6 animals. Traces of blood were seen in the intestine of 3 animals and hydronephrosis occurred in 2 rats.

Necropsy on the 6 survivors from the 2h 10 m (denoted above as 2.2h) exposure group at the end of the 14 day observation period revealed slight lung congestion in 4 of the 6 treated rats.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the Lt50 is 3.1 hours (0 hour generation time) with 95 % confidence limits of 2.4 to 3.9 hours.

Executive summary:

The toxicity of the test material via the inhalation route was investigated by exposing groups of 6 female Wistar rats to a saturated vapour of the test material for periods of 2h 10m or 4h 20m followed by an observation period of 14 days.

All rats exposed to the saturated vapour for 4h 20m died, though no mortality was seen in the experimental group with the shorter exposure period.

 

The 4h 20m exposure resulted in initial hyperactivity, severe coordination loss, breathing difficulties, anaesthesia and involuntary severe spasms of extremities. Eye irritation was also seen; reddening with excessive clear exudate. The 2h 10m exposure resulted in coordination loss and anaesthesia in all treated animals and eye irritation. Weight changes for the surviving animals were considered to be below normal.

 

Necropsy on the 6 deceased animals from the 4h 20m exposure group revealed severe lung congestion and haemorrhage, and darkened and/or mottled liver surfaces in all animals. Necropsy on the 6 survivors from the 2h 10m exposure group at the end of the 14 day observation period revealed slight lung congestion in 4 of the 6 treated rats.

 

Under the conditions of this study, the Lt50 is 3.1 hours (0 hour generation time) with 95 % confidence limits of 2.4 to 3.9 hours. Clearly toxic effects were seen; however due to a lack of quantifiable data it is not possible to correctly classify the test material in accordance with EU criteria.