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

Endpoint summary

Description of key information

LD50, oral, rat >300 < 2000 mg/kg bw (BASF, 2017)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Specific details on test material used for the study:

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

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.

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- Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.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

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).

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

In a GLP compliant study, the acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item 2-Propanamine, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl- (undiluted or preparations in deionized water) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females and 300 mg/kg bw in 6 females). Animals were observed for 14 days. 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.

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. [BASF, 2017]

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance need to be classified and labelled as acute oral category 4 under Regulation (EC) No 1272/2008.