Registration Dossier
Registration Dossier
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EC number: 274-157-0 | CAS number: 69851-61-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- limited details; no necropsy performed
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]
- EC Number:
- 245-442-7
- EC Name:
- N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]
- Cas Number:
- 23128-74-7
- Molecular formula:
- C40H64N2O4
- IUPAC Name:
- N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Purity: not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: not reported
- Weight at study initiation: average of 2933 g
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2°C
- Humidity (%): 55±5%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 14 hours light/day
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1% gum arabic in tap water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 200-300 cm2
- Fur was clipped prior to exposure
REMOVAL OF TEST SUBSTANCE
- Washing (if done): surface was washed with lukewarm water and a sponge
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2.5 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations and weighing: animal weights at the beginning and end of the study were reported; frequency of observations was not reported
- Necropsy of survivors performed: no
- The Draize method was followed.
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- not reported
- Other findings:
- No cutaneous findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (rabbit): >2000 mg/kg
- Executive summary:
An acute dermal toxicity study was performed. Three male rabbits were exposed to the test substance dermally at 2000 mg/kg for 24 hours under occlusive conditions. No mortality, clinical signs, or cutaneous reactions were observed. The LD50 in rabbits was >2000 mg/kg.
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