Bis(2-dimethylaminoethyl)(methyl)amine

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Report on Assessment of Toxicokinetic Behaviour based on literature search and Estimation of Toxicokinetics based on the toxicological test results

Adequacy of study:

key study

Study period:

From November 2012 to March 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific method and is described in sufficient detail.

Data source

Reference

Reference Type:

other: Assessment report from available information

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Objective of study:

other: Finding of all available infomation about absorption, distribution, elimination, event. metabolism of the substance and estimation of the substance fate in organism

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Evaluation of toxicokinetics of the substance Pentamethyldiethylentriamine was performed according to the demand given in part 8.8.1 of Annex VIII to the Directive (EC) No. 1907/2006 (REACH) : “Assessment of the toxicokinetic behaviour of the substance to the extent that could be derived from the relevant available information”.

Toxicokinetics of the substance was evaluated from the following sources:
- Literature data obtained from commercial and free databases and from internet data.
- Experimental data of toxicological tests (unpublished).

Literature search was performed using the selected databases from STN International (Scientific and Technical Information Network) database service containing the data about physico-chemical, ecotoxicological, medical and toxicological properties of the substances.

The results of experimental studies were used for the assessment of toxicokinetic behaviour of the test substance.

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-dimethylaminoethyl)(methyl)amine

EC Number:

221-201-1

EC Name:

Bis(2-dimethylaminoethyl)(methyl)amine

Cas Number:

3030-47-5

Molecular formula:

C9H23N3

IUPAC Name:

(2-{[2-(dimethylamino)ethyl](methyl)amino}ethyl)dimethylamine

Constituent 2

Reference substance name:

bis(2-dimethylamino)(methyl)amine

IUPAC Name:

bis(2-dimethylamino)(methyl)amine

Constituent 3

Reference substance name:

Polykat 5

IUPAC Name:

Polykat 5

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
The toxicity of the substance after acute exposure is generally low. The test substance after single oral administration of high dose level invoked the following toxic effects in the testing organism: death of animals, and clinical and pathological findings. The test substance penetrated into organism after single oral application – the systemic toxicity was observed.
After acute dermal exposure, the local changes of the test area (irritation, necrosis) were irreversible. The substance is corrosive for skin. No systemic toxicity was observed, so the substance did not enter the organism through the skin.
After acute eye exposure the substance causes irreversible local effects on the eye of the test animals. No systemic effects were reported.
Following acute inhalation exposure, no systemic toxicity was reported, so this way of entry to the organism is also not relevant.

Repeated whole-body exposure of rats to the vapor of the test substance caused extensive irritation of the upper respiratory tract, skin and eyes. The changes observed were indicative of nonselective localized irritation to tissues by exposure to the test material. Only local effects were observed, no systemic toxicity.
Repeated oral dose exposure to the test substance resulted in absorption into organism and subsequent systemic distribution. The main target organ was liver. After oral administration, the test substance caused systemic intoxication. It was relatively quickly absorbed from digestive tract and systemically distributed through the body (hours). It affected heart, liver, lungs, brain, etc. through blood circulation. With respect to reproduction toxicity part of the repeated dose study it was not possible to confirm penetration through the placental barrier.
No data about metabolism, distribution and excretion of the test substance were found.

Executive summary:

Executive summary:

Evaluation of toxicokinetics of the substance Pentamethyldiethylentriamine was performed according to the demand given in part 8.8.1 of Annex VIII to the Directive (EC) No. 1907/2006 (REACH) : “Assessment of the toxicokinetic behavior of the substance to the extent that could be derived from the relevant available information”.

Toxicokinetics of the substance was evaluated from following sources:

- Literature data obtained from commercial and free databases and from internet data.

- Experimental data of toxicological tests (unpublished).

 

Based on literature data, no concrete information about absorption, distribution, metabolism and excretion of the test substance was found.

The assessment of toxicokinetic behaviour of the substance, Pentamethyldiethylentriamine, was performed, based on the results of toxicological tests.

The test substance after single oral administration of high dose level invoked the following toxic effects in the tested organism: death of animals, and clinical and pathological findings. The test substance penetrated into organism after single oral application – the systemic toxicity was observed.

After acute dermal exposure, the local changes of test area (irritation, necrosis) were irreversible. The substance is corrosive for skin. No systemic toxicity was observed, so the substance did not enter the organism through the skin. After acute eye exposure, the substance caused irreversible local effects on eye of the test animals. No systemic effects were reported. In experiments with acute inhalation exposure, no systemic toxicity was reported, so this way of entry to the organism was not relevant also.

Repeated oral exposure of the substance resulted in entering into organism and its systemic distribution. The main target organ in organism was liver. After oral administration, the test substance caused systemic intoxication of organism. It was fairly quickly absorbed from digestive tract and systemically distributed through the body (hours). Through the blood circulation, it affected heart, liver, lungs, brain, etc.

Repeated whole-body exposure of rats to the vapor of the test substance caused extensive irritation of the upper respiratory tract, skin and eyes. The changes observed were indicative of nonselective localized irritation to tissues by exposure to the test material. Only local effects were observed, no systemic toxicity.

With respect to the results of reproduction toxicity part of repeated dose study it was not possible to confirm penetration through the placental barrier.