Pentaerythritol, ethoxylated, esters with acrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

November-December 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted according to OECD guideline No. 423 and under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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 (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol (EO)n Tetraacrylate

IUPAC Name:

Pentaerythritol (EO)n Tetraacrylate

Constituent 2

Reference substance name:

127312-13-4

Cas Number:

127312-13-4

IUPAC Name:

127312-13-4

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): MIRAMER M4004 [Pentaerythritol (EO)n Tetraacrylate]
- Molecular weight: 571
- Substance type: UVCB
- Physical state: clear liquid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Orient Bio Co. Ltd, Gyenoggi, Korea
- Age at study initiation: 8 weeks
- Weight at study initiation: 205-226 g
- Fasting period before study: one day before administarion of the test substance
- Housing:3 animals in stainless steel cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours dark./12 hours light

IN-LIFE DATES: from 11 November 2010 to 30 November 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were observed for 4 hours after treatment and then once every day for 14 days. Body weights were measured on day of receipt, day of allocation, just before treatment and on day 7 and 14 after administration.
- Necropsy of survivors performed: yes. Organs were examined for gross lession

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the experimental period.

Clinical signs:

other: No abnormalities were detected during the 14-day observation period.

Gross pathology:

No abnormalities were detected at necroscopy

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance was > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity study of the test substance was investigated in female Sprague-Dawley rats. The test subtance was administred by oral gavage to 6 rats at a dose level of 2000 mg/kg bw. No mortality occurred during the experimental period.No abnormalities were detected during the 14-day observation period. Body weight gain was considered to be normal in all animals during the 14-day observation period.

The LD50 of the test substance was > 2000 mg/kg bw.