Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1958

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restrictions (mostly due to limited documentation; nominal determination of the test atmosphere; strongly reduced turnover of the test atmosphere (maximum 20 L/h))

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1958

Report date:

1958

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted 1981, Annex

Deviations:

yes

Remarks:

determination of the test atmosphere by reweighing of a test substance column

GLP compliance:

no

Test type:

other: IHT (Inhalation hazard test)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis(6-aminohexyl)amine; hexane-1,6-diamine

EC Number:

907-605-7

Cas Number:

68815-47-4

Molecular formula:

C6H16N2 (HMD) C12H29N3 (BHT)

IUPAC Name:

bis(6-aminohexyl)amine; hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): Hexamethylendiamin-Rueckstande

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean weight at study initiation: 126 g (animals of both sexes and both trials combined)

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Rats were exposed for 8 h to a vapour saturated atmosphere.
Vapour was generated by bubbling dry air (no CO2) through the liquid substance column (volume ca. 120 ml) above a fritted glass disc in a glass cylinder. This glass cylinder was placed in an oil bath with a temperature of 50°C. Temperature in the exposure chamber was 20°C.
Due to the increasing viscosity of the test substance during the exposure period, the normally used turnover of 200 L/h dropped down to maximum 20 L/h which was about half of the needed amount of fresh air (36 L/h per 6 animals).

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

3.1 mg/L nominal

No. of animals per sex per dose:

3 animals of each sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Groupwise weighing was done on days 0, 4, 8, 11 and 15. Detailed clinical observations were performed several times at the day of exposure and daily with the exception of weekends and holidays afterwards.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

other: IHT

Effect level:

3.1 mg/L air

Based on:

test mat.

Remarks:

nominal

Exp. duration:

8 h

Remarks on result:

other: 0/6 animals died during exposure to the volatile parts of the test item for 8 h

Mortality:

0/6 animals died

Clinical signs:

other: After 40 min of exposure eyelid closure and ruffled fur, after 5 h gasping. On the day after application free from symptoms.

Body weight:

Constant body weight gain during the observation period.

Gross pathology:

not performed.

Applicant's summary and conclusion

Conclusions:

Testing for acute toxicity after exposure through inhalation a limit test equivalent to the one set out in OECD TG 403 was performed. None of the six animals (male and female rats) exposed for 8 hours to saturated vapour containing 3.1 mg test item per l air (nominal determination) died during the 14 day observation period. Having these results one could state that under the conditions tested the median lethal dose of the test item is > 3.1 mg/l.