Reaction mass of meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2 yl)phenoxy]methyl}oxirane and 2RS)-2-({4-[2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1-dichloroethylidene-2-yl]phenoxy}methyl)oxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 JUNE 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Principles of method if other than guideline:

• Groups of animals of a single sex are dosed in a stepwise procedure using the fixed doses of 300 and 2000 mg/kg.
• The initial dose level was selected on the basis of a sighting study as the dose expected to produce some signs of toxicity without causing severe toxic effects or mortality.
• Further groups of animals were dosed at higher dose depending on the presence or absence of the signs of toxicity or mortality. This procedure continues until the dose causing evident toxicity or no more than one death is identified or when no effects are seen at the highest dose or when deaths occur at the lowest dose.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene -2- yl)phenoxy] methyl} oxirane

Molecular formula:

C20 H18 Cl2 O4

IUPAC Name:

meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene -2- yl)phenoxy] methyl} oxirane

Test material form:

solid

Details on test material:

Batch GRM193K01
Manufactured 19.07.2019
exp date : 03.09.2021
Density 1.32 g/cm3 at 23°C

Specific details on test material used for the study:

                                              
Chemical Name (IUPAC): Reaction mass of meso-2- {[4-(2-{4-[(oxiran-2- yl)methoxy]phenyl}-1,1-dichloroethylidene-2 yl)phenoxy]methyl}oxirane and 2RS)-2-({4- 2- (4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1- dichloroethylidene-2- yl]phenoxy}methyl)oxirane
                                                
Related CAS No.: 69415-01-6
                                                
Physical appearance: Solid
                                                
Purity as per Certificate of Analysis: 60 -85% (No purity correction during dose formulation preparation)
                                                
Batch No.: GRM193K19
                                                
Manufactured date: 19. 07.2019
                                                
Expiry date:03.09.2021
                                                
Physico-chemical properties:Density : 1.32 g/cm3 (23 °C),pH: Not applicable
                                                
Storage conditions: Ambient (+15 to +25ºC)
                                                
Note: 1. Date of receipt of test item at test facility: 04 February 2020, 2. Test item code by test facility: H022-03

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Rats were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (13.7 air changes/hour). Environment: with temperature 21 to 25°C, relative humidity 65 to 68%, with 12 hours light and 12 hours dark cycle.

The maximum and minimum temperature and relative humidity in the experimental room were recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

As there was no complete available toxicology information about test item. Hence, the study was initiated with starting dose of 300 mg/kg body weight as sighting study.

No. of animals per sex per dose:

6

Details on study design:

Group and step Dose
(mg/kg) Concentration
(mg/mL) Volume of test item
suspension (mL) Test item
Quantity

G1
(Sighting study) 300 30 30 0.9 g
G2
(Sighting study) 2000 200 30 6.0 g
G2 (Main study) 2000 200 20 4.0 g

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Nil

Clinical signs:

other: G1 (Sighting study): There were no clinical signs and pre-terminal deaths. G2 (Sighting study): There were no clinical signs and pre-terminal deaths. G2 (Main study): There were no clinical signs and pre-terminal deaths.

Gross pathology:

There were no gross pathological changes at necropsy in the terminal sacrifice rats

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the results of the present study, The LD50 of test item, Bisphenol C Epoxy is more than 2000 mg/kg body weight

Executive summary:

The acute oral toxicity study with Bisphenol C Epoxy in Wistar rats was conducted to assess the toxicological profile of the testitem.

The dose formulation was prepared by using Corn-oil and administered as a single oral gavage to overnight fasted (16 to 18 hours) female rat (GI-sighting study) at the dose of 300 mg/kg body weight. The rat was normal and there was no pre­ terminal death observed.

As per scheme, the treatment was continued by dosing one female rat at the dose of 2000 mg/kg body weight (G2- sighting study). The rat was normal and there was no pre-terminal death observed.

Hence, as per Annexure 1 of the report the treatment was continued by dosing four additional female rats at the higher dose of 2000 mg/kg body weight (G2-main study). All rats were normal and there were no pre-terminal death observed.

The prepared dose formulation was administered at the dose volume of 10 mL/kg bodyweight.

The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8, 15 and death rats. Necropsy was performed for all the surviving rats. All surviving rats gained weight during experimental period. There were no gross pathological changes at necropsy..

Based on the results of the present study, the LD50 of the test item is >2000 mg/kg body weight.