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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 December 2018 - 17 April 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 guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

2017

Deviations:

yes

Remarks:

Temporary deviations from the minimum level of target humidity occurred for 3 days (minimum of 36%)

GLP compliance:

yes

Test type:

fixed dose procedure

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

Specific details on test material used for the study:

Batch: F288I1K351

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 (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 165 - 207g
- Fasting period before study: no
- Housing: 1 per polycarbonate cage containing sterilized sawdust
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum
- Water (e.g. ad libitum): Municipal tap-water was freely available to each animal via water bottles
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21°C
- Humidity (%): 36 to 53
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12-hour dark/12-hour light cycle

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped. The test item was applied in an area of approximately 10% of the total
body surface, i.e. approximately 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D),
successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

Duration of exposure:

24 hr

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 0, 2, and 4 hrs after dose adminstration and then once daily thereafter
Frequency of weighing: Day 1, 8, and 15
- Necropsy of survivors performed: yes
-

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mL/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No irritation was noted for any of the animals at any time point. No clinical signs were noted.

Gross pathology:

No Abnormalities

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of Soya/Linseed Oil Fatty Acid-BADGE reaction product in Wistar Han rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The objective of this study was to determine the potential toxicity of Soya/Linseed Oil Fatty Acid-BADGE reaction product, when given by a single dermal dose.

The study was carried out based on the guideline described in:

 OECD No. 402 (2017) "Acute Dermal Toxicity".

Initially, Soya/Linseed Oil Fatty Acid-BADGE reaction product was administered to 3 female Wistar Han rats by a single dermal application at 2000 mg/kg body weight for 24 hours

All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15).

No mortality occurred and no clinical signs were noted. No skin reactions were noted during the observation period. Overall, the body weight gain shown by the surviving animals during the observation period

was considered not indicative of toxicity.

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

The dermal LD50 value of Soya/Linseed Oil Fatty Acid-BADGE reaction product in Wistar Han rats was established to exceed 2000 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 dermal 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).