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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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
- Analytical 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: 214 - 255g
- Fasting period before study: overnight
- Housing: Macrolon cages type 3, 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

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: at least 10%

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24hrs


VEHICLE
- Amount(s) applied (volume or weight with unit): 4ml/kg bw

Duration of exposure:

24hrs

Doses:

200mg/kg single dose

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

not required

Details on study design:

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

Statistics:

From the body weights, the group means and their standard deviations were calculated

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured during this test

Clinical signs:

Piloerection, dyspnea and abnormal body postures were seen, being common symptoms in acute tests.

Body weight:

Recorded before exposure and at days 7 and 14
weight development within expected limits

Gross pathology:

All animals submitted to necropsy - no deviations from normal morphology were observed.

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon single dose dermal application and a 14 day post treatment observation period, no mortalities occured, all animals recovered within 10 days and no deviations noted during autopsy.

CGA 224433 tech. is therefore deemed to be relatively harmless under test conditions.

Executive summary:

Based upon the results in this test it has been concluded that the following LD50 (with 95% confidnce limits calculated where possible) was determined for CGA 224433 tech.

LD50 male = greater than 2000mg/kg bw

LD50 female = greater than 2000mg/kg bw

LD50 both sexes = greater than 2000mg/kg bw

Thus is can be concluded that no hazard classification is required for acute dermal toxicity