Formaldehyde, reaction products with bisphenol A and diethanolamine, propoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EU Method B.46 (Skin Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Reaction product of 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylated

EC Number:

926-000-9

Cas Number:

1180524-77-9

IUPAC Name:

(Reaction product of 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylated

Test animals

Species:

other: in vitro reconstructed human epidermis EST-1000 (Cell Systems, St. Katharinen, Germany)

Strain:

other: strain: not applicable

Details on test animals or test system and environmental conditions:

The model used for this study has a functional statum corneum with an underlying layer of living cells. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.

Test system

Type of coverage:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: Negative control: physiological saline solution (0.9% NaCl); Positive control: sodium dodecyl sulfate (5% SDS)

Amount / concentration applied:

30 µl test substance per insert (three replicates)

Duration of treatment / exposure:

20 min

Observation period:

42 hours post-treatment incubation period

Number of animals:

not applicable

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

exposure period 20 min., followed by a 42 hours post-treatment incubation

Value:

17

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

In vivo

Irritant / corrosive response data:

The test item was characterised by a significant impact on cell viability. Thus, the test item should be regarded as skin irritant according to UN GHS category 2.

Any other information on results incl. tables

Summary of results:

Sample No.	Test item	% Viability
1 -3	Negative Control (0.9% NaCl)	100.00
4 -6	Positive Control (0.5% SDS)	1.86
7 -9	M 530	17.06

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information

Executive summary:

The test item was tested in an in vitro skin irritation test on reconstructed human epidermis (EST-1000) according to EU method B.46 (Skin Irritation). The EST-1000 model provides a functional stratum corneum with an underlying layer of living cells. The test item was applied undiluted for 20 min followed by a 42 hour incubation time. Cell viability was determined by the MTT method. The test item was characterised by a significant impact on cell viability in this in vitro skin irritation study. Cell viability was reduced to ca. 17 % compared to negative control cultures (100%). Thus, the test item should be regarded as skin irritant according to UN GHS category 2.