Aspartic acid, N,N'-(2-methyl-1,5-pentanediyl)bis-, 1,1',4,4'-tetraethyl ester

Acute Toxicity: oral

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

Test material information

Constituent 1

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.