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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
433-260-2
EC Name:
-
Cas Number:
168253-59-6
Molecular formula:
C22H40N2O8
IUPAC Name:
1,5-bis[1,2-bis(ethoxycarbonyl)ethylamino]-2-methylpentane
Details on test material:
- Stability in vehicle: verified in an analytical test conducted under GLP

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: mean weight 216 g (for males) and 187 g (for females)
- Fasting period before study: 16-17 h
- Housing: in goups of 3 animals
- Diet and Water: ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Application volume: 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: several times on the day of administration, and at least once daily during the observation period.
- Frequency of weighing: directly before administration, after one week (only females) and at the end of the observation period or after death.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed after the application or during the 15-days post-application period.
Clinical signs:
other: No signs of intoxication occured during the observation time at all animals.
Gross pathology:
The animals sacrificed at the end of study showed no noticeable gross pathological findings.
Other findings:
None

Applicant's summary and conclusion

Executive summary:

An oral toxicity study (OECD TG 423) with a starting dose of 2000 mg/kg bw was performed with 3 male and 3 female rats. No mortality, no clinical signs and no gross pathological findings were observed after application of the test substance in the 15-days observation period. Therefore, the LD50 was estimated to be > 2000 mg/kg bw.