Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane

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:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane

EC Number:

412-060-9

EC Name:

Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane

Cas Number:

136210-32-7

Molecular formula:

C31H54N2O8

IUPAC Name:

1,4-diethyl 2-{[4-({4-[(1,4-diethoxy-1,4-dioxobutan-2-yl)amino]-3-methylcyclohexyl}methyl)-2-methylcyclohexyl]amino}butanedioate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Strain: BOR: WISW (SPF Cpb)
- Age at study initiation: approximately 8 weeks for males and 10 weeks for females
- Weight at study initiation: mean weight 182 g (for males) and 168 g (for females)
- Housing: in groups
- Diet and water: ad libitum
- Fasting period before study: approximately 16 hours
- Acclimation period: at least 4 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

The test substance was dissolved in peanut oil (DAB9) and intragastrally administered via a metal gastric tube.
Application volume: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: day 0 several times, day 1 to 14 twice daily, except for the weekend (once daily).
- Frequency of weighing: immediately after application, on day 7 and day 14.
- 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 14-days post-application period.

Clinical signs:

other: No clinical signs were observed after the application or in the 14-days post-application period.

Gross pathology:

All animals were sacrificed at the end of the 14-days observation period. There were no gross pathological findings.

Other findings:

None

Applicant's summary and conclusion

Executive summary:

An oral toxicity study with a limit dose of 2000 mg test item/kg bw was performed with 5 male and 5 female rats according to EU method B.1. No mortality, no clinical signs and no gross pathological findings were observed after application of the test substance aspartic acid, N,N'-[methylenebis(2-methyl-4,1-cyclohexanediyl)]bis-,1,1',4,4'-tetraethyl ester or in the 14-days post-application period.

Therefore the LC50 was estimated to be > 2000 mg/kg bw.