reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - April 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

EC Number:

821-997-6

Cas Number:

2136366-99-7

Molecular formula:

C11H16O6 to C21H32O8

IUPAC Name:

reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Orient Bio Co., Ltd, korea
- Age at study initiation: 8/9 weeks old
- Weight at study initiation: 201.1-218.1 g
- Fasting period before study: yes
- Housing: by 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6-22.2
- Humidity (%): 47.1-52.6
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

For 2000 mg/kg bw treatment to the animals, the test substance suspended with autoclaved distilled water to bring the formulation to 200 mg/mL test substance.

Doses:

2000 mg/kg bw

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 and weighing: Clinical signs were carefully observed for 4 hours after treatment and then an once every day for 14 days. Bodyweight was measured animal receipt day, animal allocation day, just before treatment and on day 7 and 14 after the administration
- Necropsy of survivors performed: yes, on the end of study period, all animals were examined for external findings.

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed.

Clinical signs:

other: Clinical signs related with the test substance in all animals were not observed during the observation period.

Gross pathology:

In all animals, there were no lesions caused by administration of the test substance.

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on these results, there were no mortality when the test substance was acute administrated orally at a dose volume of 2000 mg/kg bw in female rats, the oral LD50 is higher than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity study was conducted to the SD rats. The test substance was administrated only one time by oral route at a dose volume of 2000 mg/kg bw. Three animals were used for each step that divided 1 step and 2 step. Mortality, clinical signs, body weights and necropsy findings were observed for 14 days. No mortality was observed. Clinical signs related with the test substance in all animals were not observed during the observation period. All tested animals showed normal gains in body weights. In all animals, there were no lesions caused by administration of the test substance. Based on these results, there were no mortality when the test substance was acute administrated orally at a dose volume of 2000 mg/kg bw in female rats, the oral LD50 is higher than 2000 mg/kg bw.