Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

EC Number:

276-769-3

EC Name:

Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

Cas Number:

72705-22-7

Molecular formula:

C12H15NO6S.H3N

IUPAC Name:

ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

Details on test material:

purity: 93.2 % (contains residual water)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG, Kastengrund, SPF-breeding
- Weight at study initiation: males: 197 - 221 g; females: 186 - 205 g
- Fasting period before study: 16 hours
- Housing: in macrolon cages located in completely air-conditioned rooms in groups of 5 animals
- Diet: Rattendiat Altromin 1324, (Altromin-GmbH, Lage/Lippe), ad libitum
- Water: tap water from plastic dispensors ad libitum
- Acclimation period: at leasr five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%): 55+-10
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

see below

Doses:

dose concentration application volume number of animals
(mg/kg bw) (%(w/v)) (ml/kg bw) males females

5000 25 20 5 5

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: once a day and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: At the day of the application males nd females showed squatting posture, ruffled hair and restless behaviour. One day later these signs had disappeared.

Gross pathology:

the animals were free from macroscopic signs

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Since LD50 > 5000 mg/kg bw the substance is not subject for classification for acute oral toxicity.

Executive summary:

The substance was tested for acute oral toxicity according to OECD guideline 401. 5 male and 5 female Wistar-rats were administered one single dose of 5000 mg/kg bw by gavage as a suspension in water. During the observation period of 14 days no mortality occured.

Only at the day of the application the animals show signs such as squatting posture, ruffled hair and restless behaviour, but these signs disappeared one day later. There was no impact on the development of the body weight.

Therefore, the LD50 is greater than 5000 mg/kg bw.