Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
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:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Genamin CS 301
- Lot/batch No.: 06-HTW 255
- A statement of identity for Genamin CS 301 was provided on july 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 CS 301:
-> Amines, dicoco alkylmethyl CAS 61788-62-3 EC 262-990-2

No other data available.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
The animals showed impaired breathing and motion, as well as blood-colored, crusty snouts.
The symptoms were reversible by day 4.
Body weight:
No effects were noticed on body weight gain.
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.