Amines, bis(C16-18 and C18-unsatd. alkyl)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-C16-18-(even numbered, C18-unsaturated)-alkyl-1-C16-18-(even numbered, C18-unsaturated)-amine

EC Number:

696-481-5

Cas Number:

1219826-47-7

Molecular formula:

R2-NH whereas R = mainly C16-18 (even numbered, C18 unsaturated) alkyl molecular weight range is based on R =16 (lower limit value) and R = 18 (higher limit value)

IUPAC Name:

N-C16-18-(even numbered, C18-unsaturated)-alkyl-1-C16-18-(even numbered, C18-unsaturated)-amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH Gartenstrasse 27 D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 170-198 gram
- Housing: 3 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

The animals received the compound as a 10 % solution in sesame oil, the administration volume was 10 mL/kg body weight (2 applications in 30 minutes interval)

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

The prepared test substance was administered by gavage to fasted animals at 2000 mg/kg. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Statistics:

no data

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: No symptoms were observed.

Gross pathology:

No macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item is >2000 mg/kg BW.