1,3-Benzenedicarboxamide, 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-, hydrochloride (1:1)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1995-March 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study described in this report was conducted in compliance with the Good Laboratory Practice (GLP) Regulations.

Justification for type of information:

The study described in this report was conducted in compliance with the Good Laboratory Practice (GLP) Regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

yes (1. Relative humidity in the animal room 221(BRL) was normally in the range of 40-70%, however on one day (07.12.1995) the minimum recorded Relative humidity was 25%. 2. The animal diet suppliers previously named (Klingenthalmuhle A.G.) changed their name )

Deviations:

yes

Remarks:

See remarks above

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

421-690-3

EC Name:

-

Cas Number:

203515-86-0

Molecular formula:

C14H21N3O6 . ClH

IUPAC Name:

5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Duration of exposure:

4 h

No. of animals per sex per dose:

5

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 182 mg/L air

Exp. duration:

4 h

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no toxicological effects observed.

Executive summary:

The purpose of this acute 4 -hour inhalation toxicity study was to assess the acute inhalation toxicity of ABA-HCl when administered to rats for a single continuous 4 -hour period at the highest technically achievable concentration. Five male and female Albino Wistar rats were exposed by inhalation to the test article at the highest technically achievable mean concentration of 2.182 mg/l air ± 0.364 N=4 (gravimetric value). All animals were recorded for clinical signs and mortalinity during and following the inhalation exposure over a 14 day observation period. The test compound was well tolerated by the rats under the conditions applied, even at a exposure concentration of 2.182 mg/l air. Body weights were recorded prior to exposure on test day 1 and following exposure on test days 4, 8 and on the day of necropsy. All animals were necropsied and all gross macroscopical changes were recorded.

LC50 Value The LC50 of ABA-HCL obtained in this study, was estimated to be above > 2.182 mg/l air (gravimetric value). EXPOSURE CONDITIONS The ranges of btemperature, humidity and oxygen content measured during the exposures were satisfactory for a study of this type. IN-LIFE OBSERVATIONS MORTALITY No spontaneous death occured in this study. All animals were sacrificed as scheduled on test day 15. CLINICAL SIGNS During the inhalation exposure: No clinical signs were detected in any animal. After the inhalation exposure: The only clinical symptom detected in all animals was ruffled fur (5/5)* on test day 1, (1 hour after the end of exposure) No other symptoms were detected during the remainder of the observation period. BODY WEIGHTS With the exception of one male animal (no. 5) all animals gained weight over the 14 -day observation period. Three female animals (nos. 6,8 and 10) lost weight slightly between test days a and 4 but gained weight normally during the remainder of the observation period. Transient weight loss is often associated with the stress of the restraint procedures especially in female animals. PATHOLOGY MACROSCOPICAL FINDINGS The only remarkable macroscopical finding at necropsy was: lungs left lobe, focus, diameter 1 mm, reddish in appearance (1/0)*. This finding was interpreted to have been caused by vascular congestion due to euthasia. *(../..) number of male/female animals.