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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was coinducted according to OECD Guideline 402 (Acute Dermal Toxicity). The substance was administered to five rats of each sex by dermal application.. NA GLP certificate is provided. The study is otherwise well documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

223-362-3

EC Name:

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

Cas Number:

3855-32-1

Molecular formula:

C11H27N3

IUPAC Name:

(3-{[3-(dimethylamino)propyl](methyl)amino}propyl)dimethylamine

Test material form:

gas under pressure: refrigerated liquefied gas

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The substance was administered to five rats of each sex by dermal application at 2000, 1000 or 400 mg.kg body weight for 24 hours.

Duration of exposure:

24 hours.

Doses:

Dermal application at 2000, 1000 or 400 mg.kg

No. of animals per sex per dose:

5 males
5 Females

Control animals:

not specified

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1.2 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.01 - <= 2.01

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1.25 mL/kg bw

Based on:

test mat.

Mortality:

The incidence of mortality among both sexes from high to low dose group was 10, 10 and 0.

Clinical signs:

other: Hyperactivity and lethargy were noted in all animals. Prostration, bradypnoea, piloerection, ptosis, squealing and lacrimation were noted among the animals. These symptoms had disappeared in all surviving animals by day 5, although temporary piloerection

Gross pathology:

The treated skin surface among the animals showed oedema, necrosis, erythema, crusts, scaliness, a wound and new skin formation.
Macroscopic post iuortem examination of the animals that died during the study revealed greenish discolouration of the treated area, red spot in the treated area, dark redlblacklpurple colouration of the dermis beneath the treated
area, dark red colouration of the muscles under the treated area, black areas in glandular stomach, red coloured lungs and reddish liquid fn thoracic cavity. These findings were considered treatment related and toxicological significant.
Macroscopic post mortem examination of the surviving animals at termination revealed scab formation on the treated skin area, reduced seminal vesicles and thickened, grey, hard left testes grown together with the epididymis.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value in rats was determined to be 569 mg/kg bw for the sexes combined.
Due to the mortality distribution alone estimated dermal LD50 values could be calculated for males and females alone. These amounted to 569 mg/kg body weight for males alone and 569 mg/kg body weight for females alone.

Based on the results, and according to EU Directive 67/548/EEC, the substance should be classified as harmful.