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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
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
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

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.