N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

Endpoint summary

Description of key information

Oral: Rat, LD50 ca. 1360 mg/kg (standardized test protocol) [Smyth et al. 1962]

Dermal: Rabbit, LD50 ca. 260 mg/kg (standardized test protocol) [Smyth et al. 1962]

Inhalation: 8 hours IHT (standardized test protocol) No death occurred when the test animals were exposed to an atmosphere saturated with vapours of test substance [Smyth et al. 1962]

 

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)

Qualifier:

no guideline followed

Principles of method if other than guideline:

Estimation of single oral dose toxicity of the test substance by the gastric intubation of groups of male rats.

GLP compliance:

no

Species:

rat

Strain:

other: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: no
- Diet (e.g. ad libitum): Rockland rat diet


ENVIRONMENTAL CONDITIONS
not reported

Route of administration:

oral: gavage

Vehicle:

not specified

Remarks:

water or corn oil

Details on oral exposure:

No further information provided.

Doses:

No data.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Animals were observed for signs of toxicity after dosing, and throughout the 14-day observation interval. Animals were weighed prior to dosing and at the end of the observation interval. Animals that died on study were subjected to necropsy; surviving animals were sacrificed at the end of the observation interval and necropsied.

Statistics:

Thompson's method of calculating the LD50 was applied to the 14-day mortality data.

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 360 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Corresponding to a LD50 of 1,62 mL with a density of 0,8395 g/mL

Mortality:

Not reported in publication.

Clinical signs:

Not reported in publication.

Body weight:

Not reported in publication.

Gross pathology:

Not reported in publication.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 360 mg/kg bw

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

Reliability:

2 (reliable with restrictions)

Qualifier:

no guideline followed

Principles of method if other than guideline:

Penetration of rabbit skin is estimated by a technique closely akin to the one-day, cuff Method of Draize.

GLP compliance:

no

Test type:

standard acute method

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-5 months
- Mean weight at study initiation: 2.5 -3.5 kg

ENVIRONMENTAL CONDITIONS
not reported

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data.
- % coverage: No data.
- Type of wrap if used: Impervious plastic film (Cuff method of Draize).

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not more than 20 ml/kg bw.

Duration of exposure:

24 h

Doses:

no data

No. of animals per sex per dose:

4 males/treatment

Control animals:

not specified

Details on study design:

Animals were observed for signs of toxicity after dosing, and throughout the 14-day observation interval. Animals that died on study were subjected to necropsy; animals sacrificed at the end of the observation interval were also necropsied.

Statistics:

Thompson's method of calculating the LD50 was applied to the 14-day mortality data.

Sex:

male

Dose descriptor:

LD50

Effect level:

260 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Corresponding to 0,31 mL/kg, calculated with a density of 0,8395 g/mL.

Mortality:

No data.

Clinical signs:

No data.

Body weight:

No data.

Gross pathology:

No data.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

260 mg/kg bw

Additional information

Acute toxicity: oral

Acute oral toxicity of BIS-DMAPA was tested in 5 male Carworth-Wistar rats in a single dose via gavage under standardized conditions and were observed for 14 days (Smyth et al., 1962, Rel. 2). The reported acute oral LD50 was approx. 1360 mg/kg bw. No further details were available.

 

Acute inhalation toxicity

 

To evaluate the acute inhalation toxicity, group of 6 male albino rats were exposed for 8 hours to an atmosphere saturated with vapours of the test substance and observed 14 days for mortality (Smyth et al. 1962; Rel 2). Whereas only limited details on test conditions are available and the concentration of the test atmosphere was not determined, no deaths were observed up to the end of the observation period.

 

Acute dermal toxicity

 

Four male albino New Zealand rabbits per dose group (doses unknown) were treated with the test substance under standardized conditions at dose levels not specified, and were observed for 14 days (Smyth et al. 1962; Rel 2). The reported acute dermal LD50 determined according to the Thompson's method was approx. 260 mg/kg bw. No further details were available.

 

 

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 is considered to be classified for acute oral toxicity (cat. 4, H302) and acute dermal toxicity (cat. 3, H311) under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012)