Formamide, N-[[(4-methylphenyl)sulfonyl]methyl]-

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

N-[[(4-methylphenyl)sulfonyl]methyl]formamide

EC Number:

700-490-2

Cas Number:

36635-56-0

Molecular formula:

C9H11NO3S

IUPAC Name:

N-[[(4-methylphenyl)sulfonyl]methyl]formamide

Details on test material:

- Name of test material (as cited in study report): CGA 224433 tech.
- Physical state: solid
- Purity: 100%
- Lot/batch No.: P. 709027

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Initial body weight range: 177 - 219g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, std soft wood bedding
- Diet (e.g. ad libitum): NAFAG 890 Tox ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12hour/day light cycle

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: individual delivery and exhaust tubes
- Exposure chamber volume: internal active volume less than 1 litre
- Method of holding animals in test chamber: microlon animal holders
- Source and rate of air: 1.25 m/s
- System of generating particulates/aerosols: brush feed mirconizing jet mill
- Method of particle size determination: cyclone type classifier ensures only particles of correct diameter leave the jet mill
- Particle size: analysed by APS-33 Aerodynamic Particle Sizer

Analytical verification of test atmosphere concentrations:

yes

Remarks:

using Brooks Sho-Rate flow meters

Duration of exposure:

ca. 4 h

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before exposure and days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 500 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortalities occurred upon exposure to CGA 224433 tech upto maximum concentration of 5526mg/m3

Clinical signs:

other: Piloerection, hunched posture, dyspnea and reduced spontaneous activity were seen in both sexes to a similar extent All animals recovered within 2 days

Body weight:

Initial weight: 177 - 219g
Weight development of all animals within normal limits.

Gross pathology:

No treatment related deviations from normal morphology could be detected

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortalities occured upon exposure to CGA 224433 tech.

Executive summary:

Upon a 4hr aerosol inhalation exposure and a 14 -day post treatment observation period, no mortalities occured at a concentration of 5526mg/m3 which exceeds the limit for the OECD test guidelines (5000mg/m3).

It can be assumed therefore that:

LC50 males = 5500mg/m3

LC50 females = 5500mg/m3

LC50 both sexes = 5500mg/m3

Thus the material requires no hazard classification for inhalation toxicity