Registration Dossier
Registration Dossier
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EC number: 414-810-0 | CAS number: - A-88820.605
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May 1995 - 01 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- EC Number:
- 414-810-0
- EC Name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- Cas Number:
- 144163-85-9
- Molecular formula:
- Empirical formula: C25H35N2O5
- IUPAC Name:
- butanedioic acid; propan-2-ol; bis(tert-butyl N-[(4R)-5-amino-4-hydroxy-1,6-diphenylhexan-2-yl]carbamate)
- Details on test material:
- Abbott-88820 hemisuccinate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Inc; Portage Michigan for males and Raleigh North Carolina for females
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 210 to 290g
- Housing: Individual stainless steel hanging cages
- Diet :Certified Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: min 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68° to 70°
- Photoperiod (hrs dark / hrs light): 12hrs/12hrs
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- sufficient sterile water for injection to make a thick paste.
- Details on dermal exposure:
- TEST SITE
- Hair clipped from the lumbar dorsal region on day before treatment. Area of exposure: approx 10% of total body area.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The semi-occlusive dressing and gauze were removed and the treated area of the skin was rinsed with warm water to remove any residual test material. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 24hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg BW
VEHICLE
- Amount applied: Sufficient sterile water for injection to make a thick paste. - Duration of exposure:
- 24 hr
- Doses:
- 2g/kgbw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The treatment area was approx 50 x 50mm
All rats observed frequently on day of treatment and daily for 13 days for total of 14 days. The daily observations included signs of toxicity in addition to lethality and irritation at the exposure site.
All animals weighed prior to dosing and weekly thereafter.
Necropsy of survivors performed: yes, 2 weeks after treatment.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
i.e. No rats died in the study. - Clinical signs:
- other: No overt signs of toxicity or signs of irritation at the site of application were observed an any males or females.
- Gross pathology:
- Multiple grey-white plaques were noted grossly on the outer surface of the spleen in a single male rat at necropsy examination. This finding was considered incidental and not treatment related.
- Other findings:
- Analyticfal tests conducted on the test material at the end of the study indicated that the test materrial remained stable during the treatment period.
Applicant's summary and conclusion
- Conclusions:
- The acute dermal median lethal dose (LD50) of Abbott-88820 administered as the hemi-succinate salt in male and female rats was demonstrated to be greater than the limit dose, 2000 mg/kg bodyweight
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