Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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