4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco

Endpoint summary

Description of key information

The substance is neither irritating or corrosive to the skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Remarks:

Both skin irritation and skin corrosion

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-05-31 to 2018-06-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

2017-10-09

Qualifier:

according to guideline

Guideline:

other: 4.2.2 DB-ALM Protocol n° 190: SkinEthicTM HCE Eye Irritation Test Liquid (EITL)

Version / remarks:

2017-06-07

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127. Lot 170825
- Expiration date of the lot/batch: 2019-07-26

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: soluble

Species:

human

Strain:

other: RhCE

Details on test animals or tissues and environmental conditions:

Test system: Reconstructed Human Corneal Epithelium, small, age day 5 (area: 0.5 cm2)
Source:
EPISKIN SNC
4, rue Alexander Fleming
69366 - Lyon Cedex 7
FRANCE

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Application HCE unit Substance
Test substance 2 living units 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item 30 ± 2 min
Test substance 2 killed units 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item
Negative control 2 living units 30 ± 2 µl 0.01M PBS pH = 7.4
Negative control 2 killed units 30 ± 2 µl 0.01M PBS pH = 7.4
Positive control 2 living units 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl methyl acetate

Duration was 30 ± 2 min

Duration of treatment / exposure:

30 ± 2 min

Duration of post- treatment incubation (in vitro):

37 ± 2 oC, 5 ± 1 % CO2, ≥ 90% humidity for 3 hours ± 15 minutes

Number of animals or in vitro replicates:

2

Irritation parameter:

other: OD mean value, mean viability %

Run / experiment:

T1- (final), 30 min exposure

Value:

98.7

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

other: OD mean value, mean viability %

Run / experiment:

T-2 (final) 30 min exposure

Value:

95.4

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

other: OD mean value, mean viability %

Run / experiment:

Mean viablity both runs

Value:

98.7

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item- 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is considered to be not irritating or corrosive to the eye.

Executive summary:

The substance 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, was examined to eye irrittaing and eye damaging properties in a study according to OECD 492.

Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item- 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is considered to be not irritating or corrosive to the eye

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available