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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Aug 2019 - 23 Sep 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
BISPHENOL A POLYETHYLENE GLYCOL DIETHER DIMETHACRYLATE
EC Number:
609-946-4
Cas Number:
41637-38-1
Molecular formula:
C23H24O4 (C2H4O)n
IUPAC Name:
BISPHENOL A POLYETHYLENE GLYCOL DIETHER DIMETHACRYLATE
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 11 weeks old
- Weight at study initiation: 178 to 199 g.
- Fasting period before study: overnight prior to dosing and until 3-4 hours after administration of the test item
- Housing: group housed (up to 3 animals of the same dosing group together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany)
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum, throughout the study, except during designated procedures.
- Water: municipal tap-water, ad libitum
- Acclimation period: 5 days before the commencement of dosing

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 21 (18-24)
- Humidity (%): 41-73 (40-70)
- Air changes (per hr): =10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 Aug 2019 To: 17 Sep 2019

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
TEST ITEM PREPARATION: the test item was administered as received.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

CLASS METHOD
- Rationale for the selection of the starting dose: based on available toxicity data of the test item, the starting dose level was the one that was likely to produce mortality in at least some of the animals.
- The dose volume for each animal was based on the body weight measurement prior to dosing. Dose volume (mL/kg body weight) was calculated as dose level (g/kg) / spec.gravity.
- The dosing formulations were stirred continuously during dose administration.
Doses:
The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. Based on the results, one additional group was dosed at 2000 mg/kg.
No. of animals per sex per dose:
6 females (2000 mg/kg/)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day.
* Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
* Animals were weighed individually on day 1 (predose), 8 and 15. A fasted weight was recorded on the day of dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
Not performed

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
Restless behavior, hunched posture and/or piloerection were noted for the animals between days 1 and 3.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD0 value of Ethoxylated (3) bisphenol A dimethacrylate in Wistar Han rats was established to exceed 2000 mg/kg body weight.
Executive summary:

The objective of this study was to assess the toxicity of the test item when administered in a single dose to female rats at one defined dosage. The study was carried out in compliance with the guidelines described in OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method".


Ethoxylated (3) bisphenol A dimethacrylate was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).


No mortality occurred. Restless behavior, hunched posture and/or piloerection were noted for the animals between Days 1 and 3. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.


The oral LD0 value of Ethoxylated (3) bisphenol A dimethacrylate in Wistar Han rats was established to exceed 2000 mg/kg body weight.