Amines, di-C16-18-alkyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP, but inhouse quality insurance was in place

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(C16-C18)alkyl(C16-C18)alkane-1-amine

EC Number:

629-721-4

Cas Number:

308062-60-4

Molecular formula:

No molecular formula

IUPAC Name:

N-(C16-C18)alkyl(C16-C18)alkane-1-amine

Test material form:

solid

Details on test material:

Chemical name: Amines, di-C16-18 (even numbered) alkyl
EC no.: 629-721-4

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 101-122g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: in groups by sex in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum, standard laboratory rodent diet (Labsure LAD 1)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: The study was undertaken between 8 and 22 May 1987.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 10.0 ml/kg max.
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED:
10.0 ml/kg

DOSAGE PREPARATION (if unusual):
No data, the dosage was prepared on the day of dosing.

Doses:

Preliminary and main study: 5000 mg/kg bw

No. of animals per sex per dose:

Preliminary study: 2
Main study: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5days, preliminary study and 14 days, main study
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On
subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation. Individual bodyweights of rats on Days 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:-

Statistics:

None

Results and discussion

Preliminary study:

No mortality at 5000 mg/kg bw

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality at 5000 mg/kg bw

Clinical signs:

other: Pilo-erection was observed in all rats shortly after dosing. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was apparently complete by Day 2.

Gross pathology:

No effects observed

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LD50 of Bis (hydrogenated tallowalkyl) amine is greather than 5000 mg/kg bw.

Executive summary:

According to OECD401 rats were exposed to 5000 mg/kg bw. No deaths occured and no significant other effects were observed. The LD50 of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is greather than 5000 mg/kg bw.