Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Modern GLP study conducted in accordance with modern guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

EC Number:

294-705-2

EC Name:

Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

Cas Number:

91745-35-6

Molecular formula:

C72H140N2O3-C80H156N2O3

IUPAC Name:

Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

Details on test material:

Batch number E0011-039E

Test animals

Species:

rat

Strain:

other: albino

Sex:

female

Details on test animals or test system and environmental conditions:

Six female albino rats of approximately nine weeks of age were used in the study. They were individually housed during the study. The animal was maintained on a 12-hour light/dark cycle (06:00 to 18:00). Mean daily temperatures and humidities ranged from 20.8 to 21.4 deg C and 34 to 44% respectively.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bodyweight

Doses:

2,000 mg/kg bodyweight (limit test)

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: 15 minutes, 1, 2 and 4 hours after dosing, and daily thereafter.
- Frequency of weighing: Day of dosing (Day 0), Day 7 and Day 14.
- Necropsy of survivors performed: yes/no Yes.

Statistics:

Not performed. There were no deaths in the study.

Results and discussion

Effect levels

Remarks on result:

other: There were no deaths

Mortality:

There were no deaths

Clinical signs:

No clinical signs were observed, except for a transient decrease in size of faeces and/or decreased defecation in one animal during the first two days after dosing. This may have been due to the fasting period prior to dosing.

Body weight:

There were no remarkable bodyweight changes

Gross pathology:

There were no gross pathology findings.

Applicant's summary and conclusion

Conclusions:

The test material caused no mortality or signs of toxicity in this study. The acute oral LD50 of the test material in albino rats is greater than 2,000 mg/kg bodyweight.

Executive summary:

An acute oral toxcity study (acute toxic class method - limit test) of was conducted in fasted female albino rats using a dose of 2,000 mg of test material per kg bodyweight. The test material was dissolved in corn oil and administered at a dosing volume of 10 ml/kg. Three animals were dosed and, when no deaths were observed after 48 hours, a confirmatory test using a further three females was conducted. In each case, animals were maintained for a 14 -day observation period.

This GLP study was conducted in accordance with OECD Test Guideline 423.

No animals died during the study and no signs of toxicity were observed in-life or at necropsy. The acute oral LD50 of the test material in albino rats is concluded to be >2,000 mg/kg bodyweight.