Amines, di-C12-18-alkylmethyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1990-01-17 to 1990-02-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentations. Only short report available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Reliability scoring based on 1987 guideline for test n°401

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, di-C12-18-alkylmethyl

EC Number:

270-418-8

EC Name:

Amines, di-C12-18-alkylmethyl

Cas Number:

68439-75-8

Molecular formula:

C24 H51 N1 (representative formula for C12 alkyl chain)

IUPAC Name:

N-methyl-N-(C12-18)-alkyl(C12-18)-alkane-1-amine

Test material form:

liquid

Details on test material:

- Chemical name: N-methyl-N-(C12-18)-alkyl(C12-18)-alkane-1-amine
- EC number: 270-418-8

“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 198 g for male, 179 g for female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesam oil

Details on oral exposure:

- The test substance was administrated as a 20 % (w/v) mixture in sesame oil at a constant volume of 10 ml/kw to yield a dose level of 2000 mg/kg
- Sesame oil comes from Mainlan pharmaceutical factory Ltd

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- All animals were observed for 14 days following dosing. Body weights were also recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Mortality:

No deaths were observed during the study.

Clinical signs:

other: The animals showed impaired breathing and motion, as well as blood-colored, crusty snouts. The symptoms were reversible by day 4.

Gross pathology:

No abnormalities were observed at macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC

Conclusions:

Under these experimental conditions, the tested substance Genamin CS 301 is not classified according to CLP (Reg. n° 1272/2008/EC) and directive 67/548/EEC.

Executive summary:

The objective of this study was to evaluate the toxicity of Genamin CS 301 following a single oral administration in rats according to the OECD guideline 401 and to the EU Method B.1. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.

Genamin CS 301 was prepared in sesame oil and was administered by gavage under a dosage-volume of 10 ml/kg bw to 2 groups of 5 male and 5 female rats.

The experiment was performed at the limit dose level of 2000 mg/kg bw.

Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.

At the dose-level of 2000 mg/kg, no mortality and no effects on body weight gain were observed. The animals showed impaired breathing and motion, as well as blood-colored, crsuty snouts. The symptoms were reversible by day 4. There were no apparent abnormalities at necropsy.

Under these experimental conditions, the oral LD0 of Genamin CS 301 was equal or higher than 2000 mg/kg bw in rats.