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

Endpoint summary

Description of key information

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

follwing OECD Guideline for Testing of Chemicals, Section 4, No. 420, “Acute Oral Toxicity – Fixed dose procedure”, adopted: 17th December 2001.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The work was performed under the supervision of the study director and in accordance with the described procedures. It is assured that the reported results faithfully represent the raw data obtained during the experimental work. No circumstances have been left unreported which may have affected the quality or integrity of the data or which might have a potential bearing on the validity and reproducibility of this study. The study director accepts overall responsibility for the technical conduct of the study as well as the interpretation, analysis, documentation and reporting of the results.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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

Justification for classification or non-classification

The test item, Bisphenol C Epoxy is classified as follows:

• The test item is classified as “Category 5 / Unclassified” Globally Harmonized Classification system of Annexure of the Guideline, OECD 420, as there were no mortalities at 2000 mg/kg body weight.

• The test item does not meet the criteria for classification as “Category 4” (1000 mg/kg < Acute Toxicity Estimates ≤ 2000 mg/kg) as per Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, as there was no mortality observed at 2000 mg/kg body weight.

• The test item is classified as ‘Category 5’ (the dermal LD50 range of 2000 to 5000 mg/kg) as per OECD Harmonised Integrated Classification System OECD, 2001, as there was no mortality observed at 2000 mg/kg body weight.