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Toxicological information

Acute Toxicity: oral

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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

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:
No abnormalities were detected during the 14-day observation period.
Body weight:
Body weight gain was considered to be normal in all animals 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.