Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-19 zo 1988-02-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study; OECD guideline and EU method were followed

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

EC Number:

403-080-9

EC Name:

Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

Cas Number:

92484-48-5

Molecular formula:

C16 H17 N3 O4 S .Na

IUPAC Name:

sodium 3-(2H-1,2,3-benzotriazol-2-yl)-5-(butan-2-yl)-4-hydroxybenzene-1-sulfonate

Details on test material:

- Name of test material (as cited in study report): FAT 75'309/A
- Physical state: powder

Test animals

Species:

rat

Strain:

other: KFM-Han. Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG; CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Males: 192 - 200 g; Females: 164 - 177 g
- Fasting period before study: fasted for 12 to 18 hours
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, rat maintenance diet
- Water (e.g. ad libitum): Community tap water, available ad libitum
- Acclimation period: At least one week under laboratory conditions, after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4 % solution of CMC
- Amount of vehicle (if gavage): 20mL

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15
- Frequency of mortality/viability: Four times during test day 1, daily during days 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died on days 2. The following death rate was observed: 10 % at 5000 mg/kg

Clinical signs:

other: The following symptoms were observed: 5000 mg/kg: sedation, dyspnea, hunched posture, diarrhea, ruffled fur. All surviving rats had recovered within 8 observation days after test article treatment.

Gross pathology:

The following macroscopic organ changes were observed: 5000 mg/kg: dead - lung : reddish discoloration, dark-red, focus.
sacrificed : No pathologic changes.

Other findings:

NA

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was greater than 5000 mg/kg.

Executive summary:

The test article sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg according to OECD guideline 401.

The following death rate was observed: 10 % at 5000 mg/kg.

The acute oral LD50 of test item in 10 rats (5 males/5 females) of both sexes, observed over a period of 15 days, was estimated to be: greater than 5000 mg/kg.