2-[[3-(dimethylamino)propyl]methylamino]ethanol

Endpoint summary

Description of key information

1) Acute oral toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol [equivalent or similar to OECD Guideline 401 (deleted on 17 Dec. 2002)]:

- LD₅₀ in female rat: estimated to be 1537 mg/kg bw;

- LD₅₀ in male rat: estimated to be 1573 mg/kg bw.

 

2) Acute dermal toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol [equivalent or similar to OECD Guideline 402 (before 9 Oct. 2017)]:

- LD₅₀ in male rabbit (abraded skin): estimated to be 1772 mg/kg bw;

- LD₅₀ in male rabbit (intact skin): estimated to be 1808 mg/kg bw.

 

3) Acute inhalation toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol: no study available; study does not need to be conducted because the substance is classified as corrosive to the skin. 

 

4) Conclusion

All of the available studies indicate that the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol is moderate acute toxic.

Based on the results, the LD₅₀ of the registration substance is considered to be 1537 mg/kg bw via the oral route and 1772 mg/kg bw via the dermal route.

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

Study period:

04 September 1980 (started); 22 September 1980 (reported)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study report provides basic data, but some details missing including dose levels

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

Principles of method if other than guideline:

The test substance was administered to groups of male and female rats by oral gavage and observed for a period of 14 days.

GLP compliance:

no

Remarks:

study was conducted before implementation of GLP

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

male/female

Route of administration:

oral: unspecified

Doses:

1.59 mL/kg bw, 2.52 mL/kg bw and 4.00 mL/kg bw [not documented; dose volume was calculated as dose level (g/kg) / density (g/mL)]

No. of animals per sex per dose:

3 (not documented)

Control animals:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

1.7 mL/kg bw

Based on:

test mat.

95% CL:

1.47 - 1.95

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 537 mg/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD50

Effect level:

1.74 mL/kg bw

Based on:

test mat.

95% CL:

1.52 - 1.99

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 573 mg/kg bw

Based on:

test mat.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

- LD50 (male rat): 1573 mg/kg bw;
- LD50 (female rat): 1537 mg/kg bw

Executive summary:

The test item 2-[[3-(dimethylamino)propyl]methylamino]ethanol was tested in an acute oral toxicity study [equivalent or similar to OECD Guideline 401 (deleted on 17 Dec. 2002), prior to introduction of GLP].

Three female and three male rats per dose level were gavaged once with the test item at dose levels of about 1.6 mL/kg bw, 2.5 mL/kg bw and 4.0 mL/kg bw (number of animals and doses not documented in report).

The acute oral median lethal dose (LD₅₀) of the test material in the rat was estimated to be 1573 mg/kg bw for male and 1537 mg/kg bw for female rat.

Using the EU Globally Harmonised System (GHS), the substance needs to be classified as Acute tox. 4, H302.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 537 mg/kg bw

Quality of whole database:

only 1 study available; older study with limited documentation, but considered sufficient for classification and hazard identification

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 February 1981 (started); 01 April 1981 (reported)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

study was conducted before implementation of GLP

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Skin of back was shaved and, following application of the test material, was wrapped with occlusive film for 24 hours.

Duration of exposure:

24 hours

Doses:

1.59 mL/kg bw, 2.52 mL/kg bw and 4.00 mL/kg bw [dose volume was calculated as dose level (g/kg) / density (g/mL)]

No. of animals per sex per dose:

6

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

1.96 mL/kg bw

Based on:

test mat.

95% CL:

0.81 - 2.73

Remarks on result:

other: abraded skin

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 772 mg/kg bw

Based on:

test mat.

Remarks on result:

other: abraded skin

Sex:

male

Dose descriptor:

LD50

Effect level:

2 mL/kg bw

Based on:

test mat.

95% CL:

1.4 - 2.72

Remarks on result:

other: intact skin

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 808 mg/kg bw

Based on:

test mat.

Remarks on result:

other: intact skin

Mortality:

1.59 mL/kg bw: 1/6
2.52 mL/kg bw: 5/6
4.00 mL/kg bw: 6/6

Signs of toxicity were usually not observed until the day after the material was applied. Local effects were not reversible within the two-week observation period. Deaths occurred 1 to 4 days post treatment.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

- LD50 (male, abraded skin): 1772 mg/kg bw;
- LD50 (male, intact skin): 1808 mg/kg bw

Executive summary:

The test item 2-[[3-(dimethylamino)propyl]methylamino]ethanol was tested in an acute dermal toxicity study [equivalent or similar to OECD Guideline 402 (before 9 Oct. 2017), prior to introduction of GLP].

The test material was administered to six male New Zealand White rabbits by a single dermal application with 1.59 mL, 2.52 mL and 4.00 mL of the undiluted test material per kg body weight for 24 hours.

Signs of toxicity were usually not observed until the day after the material was applied. Local effects were not reversible within the two-week observation period. Deaths occurred 1 to 4 days post treatment.

The acute dermal median lethal dose (LD₅₀) of the test material in the rabbit was estimated to be 1772 mg/kg bw (abraded skin) and 1808 mg/kg bw (intact skin).

Using the EU Globally Harmonised System (GHS), the substance needs to be classified as Acute tox. 4, H312.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 772 mg/kg bw

Quality of whole database:

only 1 study available; older study with limited documentation, but considered sufficient for classification and hazard identification

Justification for classification or non-classification

On the basis of the available oral and dermal data, the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol requires classification for lethal effects following a single exposure according to Regulation 1272/2008/EC; considering the significant clinical signs of toxicity observed in the acute toxicity tests, the substance - that is a strong base with a pH of 12 - is also classified for inhalation toxicity:

• Acute toxicity - oral: Acute tox. 4; H302


• Acute toxicity - dermal: Acute tox. 4; H312


• Acute toxicity - inhalation: Acute tox. 4; H332.

In addition to classification for inhalation toxicity, the substance needs to be  labelled as EUH071: ‘corrosive to the respiratory tract’ as the data available indicate that the mechanism of toxicity is corrosivity.