3-dimethylaminopropan-1-ol

Endpoint summary

Description of key information

Acute toxicity data indicate a moderate toxicity: in rats the oral LD50 was 1860 mg/kg bw. Inhalation exposure for 1-8 hours to vapour saturated with dimethylaminopropanol (inhalation risk test) showed the potential for an acute hazard, being not sufficient for classification puposes.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication which meets basic scientific principles.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: the test substance was administered as a 15 - 35% aqueous solution.

MAXIMUM DOSE VOLUME APPLIED:
10000 ul/kg

Doses:

1470, 2150, 3160, 6810, 10000 µl/kg (1299, 1900, 2793, 6020, 8840 mg/kg)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 860 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 100 other: µl/kg bw

Based on:

test mat.

Remarks on result:

other: original value

Mortality:

1470 µl/kg: no deaths after 7 days
2150 µl/kg: 2/5 males and 3/5 females after 7 days
3160 µl/kg, 6810 µl/kg and 10000 µl/kg: all animals died within 7 days

Clinical signs:

other: dyspnoea, slight staggering, partly ventral position, apathy, reddished salivary secretion.

Gross pathology:

acute dilatation of the heart, congestive hyperemia, distinct diffuse reddening especially in the glandular stomach, partly bloody slough eschar formation, hematinized diarrheic intestine content.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 860 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral toxicity

In an oral toxicity study, comparable to OECD guideline 401, US-rats (5/sex/dose) were administered dimethylaminopropanol at 3.5, 283, 354, 442, 849 and 1697 mg/kg by single dose (gavage) followed by a 7-day observation period (BASF AG, 1969). Clinical signs included dyspnoea and staggering. Findings at necropsy included serious incrusted snouts, liquid-proliferative serous skin(s) and diarrhea. The LD50 was 354 - 442 mg/kg bw.

In another acute oral toxicity study, comparable to OECD guideline 401, Sprague-Dawley rats (5/sex/dose) were administered dimethylaminopropanol at 1470 to 10000 µl/kg (equivalent to 1299 to 8840 mg/kg) by single dose (gavage) followed by a 7-day observation period (BASF AG, 1975). Clinical signs included dyspnoea, slight staggering, partly ventral position and reddished salivary secretion. Findings at necropsy included acute dilatation of the heart, congestive hyperemia, distinct diffuse reddening especially in the glandular stomach, partly bloody slough eschar formation and hematinised diarrheic intestine content. The LD50 was 2100 µl/kg bw (equivalent to ca. 1860 mg/kg bw).

 

Inhalation toxicity

Two reports are available in which rats were exposed to a saturated dimethylaminopropanol atmosphere (concentration not given) at 20°C.

In one study no deaths were observed during a 7-day observation period after 1 hour of exposure, after 3 hours of exposure 1 out of 12 rats died during the 7-day observation period and after 8 hours of exposure 2 out of 6 rats died during the 7-day observation period (BASF AG, 1969). In this study rats were also exposed to a saturated dimethylaminopropanol atmosphere generated at 150°C, after 30 minutes of exposure no deaths were observed, after 1 hour of exposure 1 out of 12 rats died and after 3 hours of exposure 4 out of 6 rats died.

In the second study after 3 hours of exposure no deaths were observed during a 7-day observation period, at 8 hours of exposure 1 out of six rats died during the 7-day observation period (BASF AG, 1976).

Dermal toxicity

No reliable acute dermal toxicity data is available. In accordance with column 2 of REACH Annex VIII, in addition to the oral route at least one other route shall be provided. According to REACH Annex VIII no further testing on acute toxicity is necessary if the substance is classified as corrosive to the skin. Dimethylaminopropanol CAS No. 3179-63-3 is classified as corrosive to the skin and eyes according to Directive 67/548/EEC (C, R34) and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Category 1B, assigned H314, causes severe skin burns and eye damage). No further testing is necessary.

 

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, in addition to the oral route at least one other route shall be provided. According to REACh Annex VIII no further testing on acute toxicity is neccessary if the substance is classified as corrosive to the skin. Dimethylaminopropanol (CAS No. 3179-63-3) is classified as corrosive to the skin and eyes according to Directive 67/548/EEC (C, R34) and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Category 1B, assigned H314, causes severe skin burns and eye damage). No further testing is neccessary. However, some information on the inhalative acute toxicity is given as a weight-of-evidence approach.

Justification for selection of acute toxicity – dermal endpoint
In accordance with column 2 of REACH Annex VIII, in addition to the oral route at least one other route shall be provided. According to REACH Annex VIII no further testing on acute toxicity is necessary if the substance is classified as corrosive to the skin. Dimethylaminopropanol (CAS No. 3179-63-3) is classified as corrosive to the skin and eyes according to Directive 67/548/EEC (C, R34) and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Category 1B, assigned H314, causes severe skin burns and eye damage). No further testing is neccessary.

Justification for classification or non-classification

Based on the results of the acute oral and inhalation toxicity studies, dimethylaminopropanol needs to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.