2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 September 2004 - 03 December 2004

Reliability:

1 (reliable without restriction)

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

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide

EC Number:

271-865-1

EC Name:

2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide

Cas Number:

68610-44-6

Molecular formula:

not applicable, as UVCB substance

IUPAC Name:

2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide

Test material form:

solid

Remarks:

gummy solid at 25 °C

Details on test material:

- Color: Slight Pale Yellow Color
- Expiry date: August 2005
- Storage conditions: Room temperature
- Batch: R-0469-203-15
- Analytical purity: 82.9%
- Impurities: 17.1%

Specific details on test material used for the study:

The purity was taken into account for the preparation of the formulations

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier (Le Genest-Saint-Isle, France)
- Females nulliparous and non-pregnant
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: mean 193g (+/- 4g)
- Fasting period before study: animals were fasted for an overnight period of approximately 18 hours before dosing, but with free access to water
- Housing: in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 30 to 70
- Air changes (per hr): aproximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES:
First treatment: 5 october 2004
Experimental completion date (necropsy of the last animal): 26 October 2004

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Purified water prepared by the Testing Faciilty (reverse osmosis)

DOSE VOLUME APPLIED: 20mL/kg

RATIONALE FOR THE SELECTION OF THE DOSE:
Based on the information on the toxic potential of the test item, mortality was not expected. Therefore a limit test at 2000 mg/kg was conducted.
After the first assay with 3 females, no death occurred at the dose level of 2000 mg/kg. Then the results were confirmed in three other females.

Doses:

Limit test at 2000 mg/kg

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 (clinical sign and mortality): frequently during the hours following admiistration of the test item, and then, at least once a day
- Frequency of weighing: just before administration on Day 1, and then on day 8 and 15.
- Necropsy: on day 15
- Macroscopy examinations of the main organs as soon as possible after death (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any organs with obvious abnormalities)

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study

Clinical signs:

other: Hypoactivity and piloerection in all animals, and dyspnea in 3/6 females, were noted on day 1 only. No other clinical signs were noted during the study.

Gross pathology:

No apparent abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the oral LD50 of the test item is higher than 2000 mg/kg in female rats.

Executive summary:

The test item was evaluated in 6 female rats according to the OECD 423 guideline.

The test item, prepared in water, was administered by gavage under a volume of 20 mL/kg, at the dose level of 2000 mg/kg.

Mortality, clinical signs and body weight gain were checked for a period of 14 days.

No death was observed during the study.

Hypoactivity and piloerection in all animals, and dyspnea in 3/6 females were noted on day 1 only. No other clinical signs were observed.

The body weight gain was slightly reduced in 4/6 females during the second week of the study compared to CIT historical control data.

At necropsy, no apparent abnormalities were observed in any animal.