Registration Dossier
Registration Dossier
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EC number: 403-080-9 | CAS number: 92484-48-5 BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
Acute Toxicity: dermal
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:
- 1 988
- 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
- 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
Constituent 1
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:
- other: 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.
- 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.
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