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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-01-19 to 1988-02-29
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
IUPAC Name:
sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
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 10 weeks
- Weight at study initiation: Males: 243 - 273 g; Females: 177 - 202 g
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, rat maintenance diet
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Housing:Individually in Makrolon type-2 cages with standard softwood bedding
- 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

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total
body surface.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL at 2000 mg/kg

VEHICLE
- Concentration (if solution): 4%
Duration of exposure:
24h
Doses:
2000 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 observations and weighing: Body weight: Test days 1 (pre-administration), 8 and 15; Mortality/Viability: Four times during test day 1, and
daily during days 2 - 1 5.
- 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 rate 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:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survied.
Clinical signs:
Erythema on the treated skin was observed in a11 animals between 2 and 10 observation days. All rats had recovered at day 8 after treatment.
Body weight:
- males: 256 +/- 14 g on day 1; 299 +/- 16 g on day 15
- females: 192 +/- 9.2 g on day 1; 209 +/-14 g on day 15
Gross pathology:
No macroscopic organ changes were observed.
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 2000 mg/kg.
Executive summary:

The test article sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was applied to the skin of rats of both sexes by oral gavage for 24 hours at a dose of 2000 mg/kg according to OECD giudeline 402.

The following death rate was observed: 0 % at 2000 mg/kg.

Therefore, the LD50 of test item was estimated to be : greater than 2000 mg/kg.