Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study with detailed documentation, in compliance with principles of GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

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:
MAEEBP
IUPAC Name:
MAEEBP
Details on test material:
- Name of test material (as cited in study report): MAEEBP- Physical state: Colourless liquid- Composition of test material, percentage of components: 4-methacryloyl diethoxy benzophenone (purity 85 area %)- Lot/batch No.: 150301- Expiration date of the lot/batch: 01.09.2015- Storage condition of test material: Fridge: 2-8° C, keep away from light and humidity

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Number and Sex of Animals: 3 males and 6 females- Age at study initiation: At least 8-12 weeks; female animals were non-pregnant and nulliparous- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, males and females separately in a room equipped with central air-conditioning. The room temperature was maintained within the range of 22 ± 2° C, relative humidity within 55 ± 10 %. The light regimen was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures.- Diet: A laboratory food Altromin (Altromin Spezialfutter GmbH, Germany) was offered in recommended doses each day approximately at the same time after dosing.- Water: The animals received tap water for human consumption. Supply of drinking was unlimited.- Acclimation period: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.Animal Health: The health condition of animals was examined by a veterinarian before initiation of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Initially one group of 3 females was dosed. Test item-related mortality was not produced during 24 hours therefore groups of 3 females and 3 males were tested at the same dose.
Control animals:
no
Details on study design:
- Clinical observation: Animals were observed individually immediately after the administration of the test item and then ½, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.- Body weight: Individual weights of animals were determined shortly before the test item was administered and at weekly intervals thereafter. Weight differences after first and second week after administration were calculated and recorded.- Necropsy of survivors performed: All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All 6/6 females and 3/3 males survived the limit dose of 2000 mg/kg.
Clinical signs:
No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.
Body weight:
The body weights of animals were increasing during the study. No body weight losses were observed one and two weeks after administration.
Gross pathology:
All animals (6 females and 3 males) were necropsied. During necropsy, no macroscopic changes were noticed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The potential toxic effect of the test item MAEEBP was tested according to OECD Guideline 423 Acute Toxic Class (ATC) method. It can be concluded that the test item is classified in Category 5 with a LD50 cut off value equal to 5000 mg/kg, after single oral administration to Wistar rats.

Categories Display