Reaction products of Soya and Linseed Oil Fatty Acids with Bisphenol A diglycidylether

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 December 2018 - 18 April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was performed in accordance with the OECD Principles of Good Laboratory Practice as accepted by Regulatory Authorities throughout the European Union, United States of America (FDA and EPA), Japan (MHLW, MAFF and METI) and other countries that are signatories to the OECD Mutual Acceptance of Data Agreement.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

EC Number:

216-823-5

EC Name:

2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Cas Number:

1675-54-3

Molecular formula:

C21H24O4

IUPAC Name:

2,2'-[propane-2,2-diylbis(4,1-phenyleneoxymethylene)]dioxirane

Constituent 2

Reference substance name:

Fatty acids, linseed-oil, polymers with bisphenol A, epichlorohydrin and soya fatty acids

EC Number:

613-885-9

Cas Number:

66070-79-9

Molecular formula:

(C15 H16 O2 . C3 H5 Cl O . Unspecified . Unspecified)x

IUPAC Name:

Fatty acids, linseed-oil, polymers with bisphenol A, epichlorohydrin and soya fatty acids

Test material form:

liquid: viscous

Details on test material:

Clear colourless viscous liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

Test System:
Condition: Outbred, SPF-Quality
Source: Charles River Deutschland, Sulzfeld, Germany
nulliparous and non-pregnant
Age at the Initiation of Dosing: Young adult animals (approximately 10 weeks old)
Fasting period before study: overnight fast immediately before dosing and for approximately 3 to 4
hours after dosing
- Housing: in groups of up to 3 in suspended solid floor polycarbonate cages containing sterilized sawdust as bedding material
- Diet: SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany; ad libitum throughout the study, except for the period of overnight prior to dosing and until 3-4 hrs post dose administration
- Water: Municipal tap-water was freely available to each animal via water bottles
- Acclimation period: at least 5 days

Environmental Conditions
Temperature range: 20 to 21°C
Relative Humity range: daily mean relative humidity of 27 to 53%
12-hour light/12-hour dark cycle
Ten or greater air changes per hour with 100% fresh air (no air recirculation)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

two consecutive groups of three female Wistar Han rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: CLinical Observations at 0, 2 and 4 hr after dosing on day 1 and then once daily. Morbidity and mortality checks were made twice daily, early and late during normal working
days, and once daily at weekends and public holidays.
Frequency of weighing: Days 1 (predose), 8 and 15
days, and once daily at weekends and public holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Mortality:

No unscheduled deaths

Clinical signs:

other: Hunched posture and piloerection were noted for the animals on Days 1 and/or 2

Gross pathology:

No Abnormalities

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of Soya/Linseed Oil Fatty Acid-BADGE reaction product in Wistar Han rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 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 or more defined dosages. The study was carried out in compliance with the guidelines described in:

 OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method".

 EC No 440/2008, part B: "Acute Oral Toxicity, Acute Toxic Class Method".

 EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity".

 JMAFF Guidelines (2000), including the most recent revisions.

Soya/Linseed Oil Fatty Acid-BADGE reaction product 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.

Hunched posture and piloerection were noted for the animals on Days 1 and/or 2.

The 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.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of Soya/Linseed Oil Fatty Acid-BADGE reaction product in Wistar Han

rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed

5000 mg/kg body weight.

Based on these results, Soya/Linseed Oil Fatty Acid-BADGE reaction product does not have

to be classified and has no obligatory labelling requirement for acute oral toxicity according

to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of

the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on

classification, labelling and packaging of items and mixtures (including all amendments).