N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1988-02-08 to 1988-02-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

Genamin SH 301

IUPAC Name:

Genamin SH 301

Constituent 2

Reference substance name:

Amines, di-C14-18-alkylmethyl

EC Number:

266-923-8

EC Name:

Amines, di-C14-18-alkylmethyl

Cas Number:

67700-99-6

IUPAC Name:

N-hexadecyl-N-methylhexadecan-1-amine

Details on test material:

- Name of test material (as cited in study report): Genamin SH 301
- A statement of identity for Genamin SH 301 was provided on june 2009 by the sponsor Clariant Produkte GmbH (see attached background material). The statement specifies that the following chemical names, CAS registration and EC numbers are appropriate synonyms to describe GENAMIN SH 301:
-> Amines, bis(hydrogentated tallow alkyl)methyl CAS 61788-63-4 EC 262-991-8
-> Amines, di-C14-18-alkylmethyl CAS 67700-99-6 EC 266-923-8
- Physical state: dark red coloured cream
- Analytical purity: 100%
- Density: 0.81 kg/l at 50 °C
- Storage condition : at 22 °C in darkness
- Lot/batch No.: HTWC 255 0000

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: about 170 g
- Acclimation period: > 5 days
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Age at study initiation: 6 weeks (male) and 8 weeks (female)
- Acclimation period: at least five days
- Diet : ad libitum with Altromins 1324, except between 16 hours before and 4 hours after the test compound administration (no food)
- Water : ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature 22+/-3°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesam oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): dose volumes were calculated from the fasting body weights of the rats and the selected dose volume was 10 ml/kg
body weight.
-The test substance was dissolved in sesame oil warmed to 35 °C.

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
- Frequency of observations and weighting: once daily and weighing at 0, 7 and 14 days after exposure
- Necropsy of survivors performed: yes

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.
cf table 1 in results and discussions free text

Clinical signs:

No systemic clinic signs were observed during the study at the dose-levels of 2000 mg/kg bw.

Body weight:

cf table 2 in results and discussions free text

Gross pathology:

No abnormalities were observed at macroscopic examination.

Any other information on results incl. tables

Summarized results:

Table 1:Summarized results of cumulative mortality by sex

Acute oral toxicity, limit test, cumulative mortality
Day	Dose (mg/ kg bw)	Sex	Dose (mg/ kg bw)	Sex
	2000	F	2000	M
	Cumulative mortality		Cumulative mortality
0	0/5		0/5
1	0/5		0/5
2	0/5		0/5
3	0/5		0/5
4	0/5		0/5
5	0/5		0/5
6	0/5		0/5
7	0/5		0/5
8	0/5		0/5
9	0/5		0/5
10	0/5		0/5
11	0/5		0/5
12	0/5		0/5
13	0/5		0/5
14	0/5		0/5

Table 2:Summarized results for body weight

Acute oral toxicity, limit test, 2000 mg/kg bw
Sex			Mean body weight in grams
			Day 0	Day 7	Day 14
M			170	233	248
M			173	244	261
M			171	235	250
M			171	237	257
M			170	244	261
F			175	198	205
F			170	200	209
F			177	209	232
F			176	202	220
F			171	203	215

   

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 SH 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 SH 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 SH 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.

Based on a preliminary study indicating no deaths in 1 male and 1 female rats at 2000 mg/kg bw, the main 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, no clinical signs and no effects on body weight gain were observed. There were no apparent abnormalities at necropsy.

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

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