N,N'-ethylenebis[N-acetylacetamide]

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study cannot be subsumed under a testing guideline and was not performed in accordance with GLP, however, is well documented and scientifically acceptable. The investigation is rated as reliable with restrictions (data quality score 2).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

not applicable

Principles of method if other than guideline:

Wistar rats were exposed in inhalation chambers to TAED dust for 23 consecutive working days, 5 hours/day. Parameters examined included: mortality, body weight and body weight gain, macroscopical examination at necropsy, organ weights (liver and kidney ) and histopathological examination of the respiratory system, liver and kidneys.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-ethylenebis[N-acetylacetamide]

EC Number:

234-123-8

EC Name:

N,N'-ethylenebis[N-acetylacetamide]

Cas Number:

10543-57-4

Molecular formula:

C10H16N2O4

IUPAC Name:

N,N'-ethylenebis[N-acetylacetamide]

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

5 hours/day for 23 days

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
141 mg/m3 on day 1, 145 mg/m3 on day 2 -10, 212 mg/ m3 on day 11 -15 and 508 mg/ m3 on day 16 -23; mean TAED concentration of 283 mg/m3 calculated for the total treatment period
Basis:
nominal conc.

No. of animals per sex per dose:

10 males and 10 females

Control animals:

yes

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Effect level:

>= 283 mg/m³ air

Sex:

male/female

Basis for effect level:

other: no adverse effects observed

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

RS-Freetext:
All animals survived the exposure period.The body weights and body  weight gains of the treated animals did not differ from the control rats.  According to the study report, clinical signs were not recorded during  the treatment period. No macroscopically visible changes were observed at  necropsy. Liver and kidney weights, which were the only organ weights  determined, were comparable to control. Histopathological examination of  the respiratory system, liver and kidneys revealed no substance related effects.

Applicant's summary and conclusion

Executive summary:

Subacute inhalation toxicity was evaluated in 10 male and 10 female Wistar rats exposed in inhalation chambers to TAED dust for 23 consecutive working days, 5 hours/day, at levels of 141 mg/m3 on day 1, 145 mg/m3 on day 2-10, 212 mg/ m3 on day 11-15 and 508 mg/ m3 on day 16-23. A mean TAED concentration of 283 mg/m3 was calculated for the total treatment period. A control group of 10 male and 10 female animals was included in the study. All animals survived the exposure period. The body weights and body weight gains of the treated animals did not differ from the control rats. According to the study report, clinical signs were not recorded during the treatment period. No macroscopically visible changes were observed at necropsy. Liver and kidney weights, which were the only organ weights determined, were comparable to control. Histopathological examination of the respiratory system, liver and kidneys revealed no substance-related effects.