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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.11.2003 - 3.12.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one
EC Number:
608-748-5
Cas Number:
324763-46-4
Molecular formula:
C25 H39 N3 O5
IUPAC Name:
(3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TOP VELAZ s.r.o., závod Kolec
- Weight at study initiation: 130 - 150 g
- Fasting period before study: 20 h before until 3h after application of the test substance
- Housing: animals were housed per sex in groups, in plastic breeding cages Velaz T4
- Diet: ST 1 BERGMAN - standard pellet diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 18.11.2003
To: 03.12.2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 animals (3 males and 3 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed twice daily for clinical signs and mortality on Days 1 and 2 and once daily thereafter until Day 15. The weight of each animal was estimated before application, on Day 8 and on Day 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

The test substance in the dose 2000 mg/kg caused death of no animals, some mild clinical signs of intoxication were observed in all animals, macroscopic changes were diagnosed during pathological examination of all animals. The lung (oedema, small haemorrhage in all six animals) and heart (degeneration of myocardium in 2/3 males) were the most affected organs, but basic vital functions were not damaged and the test animals did not die. Other expressive signs of intoxication were not observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to REGULATION (EC) No 1272/2008 (CLP) the test substance does not require classification for acute oral toxicity.

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