Amides, C8-18 (even numbered) and C18 (unsaturated) alkyl, N-[3-(dimethylamino)propyl]

Acute Toxicity: oral

Administrative data

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: Well conducted study with limitation (documentation in german, without GLP)

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Orientation study to determine the acute oral toxicity. Two dosages used, compareable to OECD fixed dosed procedure (420).

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dehyton K-precursor

IUPAC Name:

Dehyton K-precursor

Details on test material:

Conversion product of coconut fatty acid with N,N disubstituted propylendiamine.

Test animals

Species:

rat

Strain:

other: Bor:WISW, Fa. Winkelmann, Borchen.

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Fa. Winkelmann, Borchen
- Weight at study initiation: 172/175 or 151/165 g
- Fasting period before study: yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

application of the pure or water diluted test item was performed via gavage after fastening

Doses:

2000mg/kg bw, 200mg/kg bw (diluted with dest. water)

No. of animals per sex per dose:

2-5 male
2-5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, gross pathology

Statistics:

no statistical tests are conducted

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: only two dosages tested

Mortality:

2000mg/kg bw:
20% dead males
80% dead females

200mg/kg bw:
0% dead males
0% dead females

Clinical signs:

other: 2000mg/kg bw: piloerection, reduced activity, heavy breathing, easily scared behaviour, wobbling motion, Diarrhoea, red-braun fur in head area, semi closed eyes 200mg/kg bw: no unusual signs

Gross pathology:

2000 mg/kg bw:
Fluffy stomach content, baggy appendix, unformed rectum content, red area in the left proventriculus (typical area for application caused irritation), pulmonary emphysema

200mg/kg bw:
no unusual signs

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS (REGULATION (EC) No 1272/2008)

Conclusions:

Based on the available finding (LD50(f) >200 < 2000 mg/kg bw) the substance has to be classified as

Executive summary:

The conversion product of coconut fatty acid with N,N disubstituted propylendiamine was test in a orientation study to determine the acute oral toxicity. Therefore to dosages (2000mg/kg bw and 200mg/kg bw) of the test substance were applied via gavage to 2-5 female and male strain Bor:WISW, Fa. Winkelmann, Borchen. Clinical signs were observed for a period of 14days and gross pathology was conducted.

The 2000mg/kg group shows 20% dead males and 80% dead females. Clinical signs are piloerection, reduced activity, heavy breathing, easily scared behaviour, wobbling motion,

Diarrhoea, red-braun fur in head area, semi closed eyes, whereas the 200mg/kg bw group reveals no death or any other usual signs.

Therefore the LD50 was determined to be >2000 mg/kg bw for males and >200 mg/kg bw <2000 mg/kg bw for females.