7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 29 May 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

EC Number:

276-957-5

EC Name:

7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

Cas Number:

72869-86-4

Molecular formula:

C23H38N2O8

IUPAC Name:

2-[({2,2,4-trimethyl-6-[({2-[(2-methylprop-2-enoyl)oxy]ethoxy}carbonyl)amino]hexyl}carbamoyl)oxy]ethyl 2-methylprop-2-enoate; 2-[({2,4,4-trimethyl-6-[({2-[(2-methylprop-2-enoyl)oxy]ethoxy}carbonyl)amino]hexyl}carbamoyl)oxy]ethyl 2-methylprop-2-enoate

Test animals

Species:

rat

Strain:

other: KFM-Han Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 200 - 234 g (males), 167 - 182 g (females)
- Fasting period before study: 12 - 18 h
- Housing: in groups of 5 in Macrolon type 3 cages with standard softwood bedding
- Diet: pelleted standard Kliba 343, batch 98/84 rat maintenance diet (Klingentalmuehle AG, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 May 1984 To: 29 May 1984

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% CMC (carboxymethlcellulose) natriumsalt purum in distilled water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION: the test substance and vehicle were added to a glass beaker and a weight by weight suspension was prepared using a homogenizer. The homogeneity of the suspension was maintained during treatment using a magnetic stirrer.

Doses:

5000 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 and weighing: Animals were observed for mortality and morbidity, and clinical signs were noted 4 times on Day 1 (day of administration) and daily thereafter. The body weight was recorded on Day 1 (prior to administration), Day 8 and Day 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: 5/5 males and 5/5 females exhibited dyspnea on Day 1 until 5 h after dosing. Ruffled fur was observed in 5/5 males and 5/5 females 1 - 2 h after administration, and a curved body position was observed in 5/5 males and 5/5 females 1 - 3 h after dosing on D

Gross pathology:

The necropsy did not show substance-related findings.

Any other information on results incl. tables

Table 1. Acute oral toxicity

Dose [mg/kg bw]	Mortality	Clinical signs
	N*	N*
Males
5000	0/5	5/5
Females
5000	0/5	5/5

*N= Number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:

other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified