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Toxicological information

Acute Toxicity: inhalation

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1958
Report date:
1958
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

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine
EC Number:
907-605-7
Cas Number:
68815-47-4
Molecular formula:
C6H16N2 (HMD) C12H29N3 (BHT)
IUPAC Name:
Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine
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.