N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl-propan-2-amine

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

12,12-dimethyl-2,5,8-trioxa-11-azatridecane

EC Number:

814-433-5

Cas Number:

926622-96-0

Molecular formula:

C11 H25 N O3

IUPAC Name:

12,12-dimethyl-2,5,8-trioxa-11-azatridecane

Test material form:

liquid

Details on test material:

- State of aggregation: liquid
- Purity: 99.8 corrected area-% by GC/FID For details see analytical report 17L00283.

- Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature
- Physical state / color: Liquid / colorless, clear
- Density [g/mL]: 0.921 (determined by Bioassay Laboratories)

Specific details on test material used for the study:

Test item No.: 17/0250-1
Batch identification: BA1948
Expiry date: May 01, 2019

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

- Nulliparous and non-pregnant female animals were used
- Acclimatization period of at least 5 days before the beginning of the experimental phase
- The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C +/- 3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Single oral administration by gavage.
- Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.

Doses:

300 mg/kg and 2000 mg/kg (undiluted)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and sacrifice moribund on study day 3.
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs, body weight, mortality

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

In the single 2000 mg/kg bw test group one animal died at hour 5 and one animal was sacrificed in a moribund state on study day 3. No mortality occurred in both 300 mg/kg bw test groups.

Clinical signs:

other: In the surviving animal of the single 2000mg/kg bw test group dyspnea and cowering position was seen from hour 1 until day 1 after administration. Poor general state was noted from hour 1 until hour 2, which regressed to impaired general state from hour 3

Gross pathology:

The following macroscopic pathologic findings were observed in the animal which died in the 2000 mg/kg bw test group:
o Dark discoloration of the liver
o Red discoloration of the stomach mucosa with blistering (filled with liquid) and detachment

The following macroscopic pathologic findings were observed in the animal which was sacrificed moribund in the 2000 mg/kg bw test group:
o White discoloration with black spots of the glandular stomach o White discoloration of the small intestine. There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (2000 mg/kg bw: 1 female; 300 mg/kg bw: 6 females).

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study the median lethal dose of 2-Propanamine, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl- after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Executive summary:

Under the conditions of this study the median lethal dose of 2-Propanamine, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl- after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.