Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: Waxy - solid

Details on test material:

None

Specific details on test material used for the study:

Identification: Sapamine CSN
Batch: 0024141800
Purity: not supplied
Expiry date: not supplied
Storage Conditions: room temperature in dark.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 164 - 187 g
- Fasting period before study: overnight
- Housing: Group of up to four in suspended solid - floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 June 2013 To: 18 July 2013

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/ suspend in distilled water.


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2, and 4 hours after dosing and then daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

standard tests performed

Results and discussion

Preliminary study:

Evaluation of data including identification of the number of animals that died during the study (or that were killed for humanity reasons), and determination of the nature, severity, onset and duration of the toxic effects.
Signs of evident toxicity were described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on body weights and abnormalities noted at necropsy were also identified.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities noted.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.

Executive summary:

Following OECD TG 420 "Acute Oral Toxicity – Fixed Dose Method" Wistar rats were exposed to test substance FAT 93580/A to determine median lethal concentration (LD50).

Total of 5 fasted female Wistar rats were treated by oral gavage with FAT 93580/A at 2000 mg/kg body weight. The test item was suspended in vehicle (Arachis oil) at a concentration of 200 mg/mL and administered at a volume of 10 ml/kg.

 

All animals survived until the end of the study period and no signs of systemic toxicity were noted during the observation period. All animals showed expected gains in body weight over the observation period and no abnormalities were noted at necropsy.

 

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.