Formaldehyde, oligomeric reaction products with 4,4'-isopropylidenediphenol and m-phenylenebis (methylamine)

Endpoint summary

Description of key information

The test item, EK195, elicited a mean tissue viability of 23.9% for three minute contact and 6.7% for one hour contact and was predicted as corrosive in the EpiDerm™ skin corrosivity test.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

GLP compliance:

yes

Test system:

human skin model

Source species:

human

Details on animal used as source of test system:

EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received : 14 June 2016
EpiDermTM Tissues (0.63cm2) lot number : 23341
Assay Medium lot number : 060916ZSA
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was stored in a refrigerator until use.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 uL

Duration of treatment / exposure:

3 minute
60 minute

Duration of post-treatment incubation (if applicable):

3 hours

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minute

Value:

23.9

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minute

Value:

6.7

Negative controls validity:

valid

Positive controls validity:

valid

Exposure Period	Percentage Viability
	Negative Control	Positive Control	Test Item
3 minute	100*	12.2	23.9
60 minute	100*	2.2	6.7

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered to be corrosive to the skin. EU CLP/UN GHS: H314/Category 1A. UN packing group I.

Executive summary:

The aim of this study is to evaluate the skin corrosion potential of the test item, EK195.

The test item was applied for three minutes and one hour to the EpiDerm™ three-dimensional human skin model. The model consisted of normal, human-derived epidermal keratinocytes, which had been cultured on 0.6 cm2 inserts to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The formazan produced was quantified by spectrophotometric measurement. The prediction model uses the percentage viability values (compared to negative control viability) at three minute and one hour exposure times to identify corrosive and non-corrosive items.

The test item, EK195, elicited a mean tissue viability of 23.9% for three minute contact and 6.7% for one hour contact and was predicted as corrosive in the EpiDerm™ skin corrosivity test.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)