Amines, di-C12-18-alkylmethyl

Endpoint summary

Description of key information

The acute oral toxicity of the substance was assessed using:

- An acute oral toxicity limit test performed in rats according to OECD 401 guideline and Good Laboratory Practices (Hoechst, 1990).

The substance is of low  acute toxicity following oral exposure:

The oral LD0  was found to be greater than 2000 mg/kg bw in both sexes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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

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.

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.

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The acute oral toxicity study was reliable with some restrictions due to limited information mentioned in the report.

The Hoechst study (1990) was performed 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.

The substance 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 rat. 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, crusty snouts. The symptoms were reversible by day 4. There were no apparent abnormalities at necropsy.

The oral LD50 was found to be higher than 2000 mg/kg bw in rats.

Justification for classification or non-classification

According to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC, the substance is not classified for acute toxicity.