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Toxicological information

Acute Toxicity: oral

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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

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

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:
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 Day 1.
Body weight:
No effect on body weight was noted.
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