A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 21 - April 03, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EEC Part B

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

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)

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
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 109 to 121 g
- Fasting period before study: overnight.
- Housing: individually in hanging stainless steel cage
- Diet: Certified Rodent Chow ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature: 71 - 72°F
- Humidity : Ambient
- Photoperiod :12hrs light/12rhs dark

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: 0.2% Hydroxypropyl methyl cellulose

Details on oral exposure:

Since the test material was found to be relatively non toxic, a limit dose of 2000mg/kg BW was the dose administered.
dose level: 2000 mg/kg
concentration: 10 ml/kg

Doses:

Single dose: 2g/kgBW at a dose level of 10ml/kgBW

No. of animals per sex per dose:

5 females/males per dose

Control animals:

no

Details on study design:

All animals were observed frequently on day of trestment and daily thereafter for at least 13 days after treatment for a total of 14 days. Day of treatment = day 0.
Daily observations included signs of toxicity in addition to lethality.
Animals weighed on a weekly basis.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was 0 (zero) mortality

Clinical signs:

other: Decreased activity was noted in all male and female rats on the day of treatment. No other signs of toxicity were noted. None of the animals died.

Gross pathology:

No gross morphological changes were noted in rats that were euthanized and necropsied at the end of the two week observation period following treatment.

Applicant's summary and conclusion

Conclusions:

LD50 was greater than the limit dose of 2000mg/kg BW