3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

20th September 1978 to 11th October 1978

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

EC Number:

213-485-0

EC Name:

3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Cas Number:

957-68-6

Molecular formula:

C10H12N2O5S

IUPAC Name:

(6R,7R)-3-[(acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

7-Aminocephalosporansäure Op. 109/78

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight of six male rats: 225 g - 244 g
Weight of six female rats: 223 g - 245 g

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

The rats were exposed individually in cylindrical synthetic cages - with defined dust concentrations. The synthetic tubes leading to the exposure cylinder, are arranged in that way that only the noses of the animals are located inside the cylinder. The inhalation chamber itself consists of a 60 liter glass-and stainless steel cylinder which is in a fume hood. To avoid the in the dispersion of the dust occurring electric charges and the resulting agglomeration the exposure cylinder is grounded. At the bottom of the inhalation chamber a suction device with which the dust-air mixture was extracted at a vacuum of 1700 L/hour over a Ciber cotton wool filter and a wash bottle filled with water. The dust exiting by the gauge pressure out of the inhalation chamber was sucked into a gas purification plant, in which the complete detoxication occurred. As dust generator a modified Exactomat 3 B of A. Platsch, Stuttgart-Vaihingen was used. The dust produced by the vibratory feeder was directed by an air volume of 1500 L/hour into the exposure chamber.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

Group 1: 0.90 - 1.34 g 7-ACA/mE03
Group 2: 1.44 - 2.11 g 7-ACA/mE03

Control animals:

no

Details on study design:

During the inhalation the animals' behavior was observed and recorded accurately. After the inhalation, the animals were kept for 14 days under observation. During this follow-up period in which the animals were kept in synthetic cages on softwood pellets, they received tap water for drinking and ALTROMIN 1324 of the company Altromin GmbH, Lage / Lippe. The animals were killed after the follow-up period under anesthesia, dissected and examined macroscopically. The aerosol dust concentration in the inhalation chamber was determined gravimetrically.

Results and discussion

Mortality:

No animals were dead after exposure.

Clinical signs:

other: The rats showed accelerated breathing and closed palpebral fissures.

Body weight:

All rats of group 1 and the male rats of group 2 showed a normal body weight developement in 14 days after exposure. The female rats of group 2 showed an irregular body weight developement in 14 days after exposure. They did not reach their body weight before exposure.

Gross pathology:

No macroscopical findings.

Applicant's summary and conclusion

Conclusions:

All animals survived the exposure for 4 hours. The rats showed accelerated breathing and closed palpebral fissures. The autopsy of killed animals after exposure showed no macroscopical findings.