Esterification products of 4,4'-isopropylidenediphenol, ethoxylated and 2-methylprop-2-enoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 December 2019 - 02 January 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 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

2017

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid

EC Number:

935-411-2

Cas Number:

not available

Molecular formula:

C23H24O4 (C2H4O)n

IUPAC Name:

Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Charles River Deutschland, Sulzfeld, Germany
- 3 females (nulliparous and non-pregnant)
- Age at study initiation: Young adult animals (approximately 10-11 weeks old)
- Weight at study initiation: 194 - 212 g
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.). During the study animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days

Periodic analysis of the water was performed and feed was analyzed by the supplier for nutritional components and environmental contaminants. It is considered that there were no known contaminants in the feed or water that would interfere with the objectives of the study.

ENVIRONMENTAL CONDITIONS
Temperature (°C): 20 - 21
Humidity (%): 43 - 53
Air changes (per hr): >= 10
Photoperiod (hrs dark/hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
Area of exposure: 18 cm^2
% coverage: approx. 10% of the total body surface
Type of wrap if used: 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.

REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

3 females at 2000 mg/kg bodyweight

Control animals:

not required

Details on study design:

RANGEFINDING STUDY
A range finding study was performed in order to select the dose causing no mortality or significant toxicity to be used in the main study. One animal was dosed at 2000 mg/kg bw.

MAIN STUDY
- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of dosing (at least three times) and once daily thereafter
- Mortality: twice daily
- Body weights: on day 1 (pre-dose), 8 and 15
- Irritation: The skin reactions were assessed approximately 24, 48 and 72 hours after the removal of the dressing and test item. Adjacent areas of untreated skin of each animal served as controls.
- Necropsy of survivors performed: yes

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:

other: No signs of systemic toxicity were observed.

Gross pathology:

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

Other findings:

Irritation effects: Very slight erythema was noted in the treated skin-area of one animal on Days 4 and 5 only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an acute dermal study, performed according to OECD guideline 402 and GLP principles, the dermal LD0 value of Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid in Wistar Han rats was determined to exceed 2000 mg/kg bodyweight. As a consequence, Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid is not classified according to CLP criteria.

Executive summary:

An acute dermal study was performed according to OECD guideline 402 and GLP principles. Three female rats were exposed at test item concentration of 2000 mg/kg bodyweight and observed for 14 days. No mortality occured. Very slight erythema was noted in the treated skin-area of one animal on Days 4 and 5. No unexpected changes in body weight gain occurred, no clinical signs were observed and no abnormalities were seen at necropsy. These results demonstrate that the dermal LD0 value of Ethoxylated (3) bisphenol A dimethacrylate in Wistar Han rats exceeds 2000 mg/kg bodyweight. As a consequence, Ethoxylated (3) bisphenol A dimethacrylate is not classified according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).