Hexanedioic acid, polymer with 2,2'-oxybis[ethanol]

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:

other: Study performed according to OECD guideline 439 and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol]

EC Number:

618-460-1

Cas Number:

9010-89-3

Molecular formula:

(C6 H10 O4 . C4 H10 O3)x

IUPAC Name:

Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol]

Constituent 2

Reference substance name:

Polyesterol 90212

IUPAC Name:

Polyesterol 90212

Test material form:

other: liquid

Details on test material:

ca. 99% (w/w) Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] / Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] / 9010-89-3

IMPURITIES
ca. 2% (w/w) 2,3,7,8-tetrahydro-2,5,8-benzotrioxacycloundecine-1,9-dione / 1,4,7-Trioxacyclotridecane-8,13-dione / 1,4,7-Trioxacyclotridecane-8,13-dione / 6607-34-7

ca. 10 ppm tin bis(2-ethylhexanoate) / Bis(2-ethylhexanoyloxy)tin / Hexanoic acid, 2-ethyl, tin(2+) salt (2:1) / 301-10-0

ca. 10 ppm titanium tetrabutanolate / titanium tetrabutanolate / tetrabutyl titanate / 5593-70-4

Test animals

Species:

other: 3D human epidermis model

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

30 ul of undiluted test substance.

Duration of treatment / exposure:

25 minutes under the laminar flow hood at room temperature and for 35 minutes in the incubator at 37 °C.

Details on study design:

PRETEST
A pretet to assess the ability of the test substance to directly reduce MTT was performed. The test substance was added to 0.9 ml of MTT solution. The mixture was incubated in the dark at 37 °C for 55-65 minutes. A negative control with dioinized water was tested concurrently.

SKIN IRRITATION TEST
The EpiDerm test was conducted with the Epi-200 tissue model (MatTek Corporation, Ashland MA, USA). The tissues were preconditioned in 6-well-plates containing 0.9 ml assay medium in the incubator at 37 °C for 1 hour. After that, the medium was replaced with fresh medium and the tissues were preconditioned for another 18+/-3 hours. The tissues were then treated with the test substance and positive (5% SDS) and negative (PBS) controls, respectively (3 tissues per group). A nylon mesh was placed on the control tissues as spreading support. The tissues were incubated at room temperature for 25 minutes and in the incubator for 35 minutes. 1 hour after application, the tissues were washed with PBS, dried, transferred into new 6-well-plates containing fresh medium and incubated at 37 °C for 24+/-2 hours. Subsequently, the tissues were again transferred into new 6-well-plates containing fresh medium and incubated for additional 18+/-2 hours of post-incubation. The medium was then replaced with MTT solution. After 3 hours of incubation, the tissues were washed and incubated with isopropanol to extract the metabolically formed formazan. The optical density at 570 nm was determined spectrophotometrically.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: tissue viability, presented as the quotient of the mean OD570 divided by the respective OD570 NC value in %.

Value:

> 50 - <= 100

Remarks on result:

other:

Remarks:

Basis: mean. Max. score: 100.0. Reversibility: no data. Remarks: A chemical is considered as irritant if the mean relative tissue viability is <=50%.. (migrated information)

Any other information on results incl. tables

ACCEPTANCE CRITERIA

Negative control:

Tissue viability is acceptable if the mean OD570 of the negative control is >=1.0 (should not exceed 2.5).

Positive control:

5% SDS is used as positive control and reflects the sensitivity of the tissues used. A viability of <=20% is acceptable.

Inter-tissue variability between two identically treated tissues is considered to be acceptable if the standard deviation is <=20%.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Irritant potential is predicted from the mean relative tissue viabilities compared to the negative control. A chemical is considered as "irritant", if the mean relative tissue viability is <=50%.

Conclusions:

Under the test conditions chosen, Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] does not show a skin irritation potential in the EpiDerm skin irritation test.

Executive summary:

The test substance Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] was tested for skin irritation in the EpiDerm^TM test following OECD guideline 439 with the Epi-200 tissue model (MatTek Corporation, Ashland MA, USA). The tissues were preconditioned first for 1 hour and after a medium change for another 18+/-3 hours. Subsequently, the test substance and positive (5% SDS) and negative (PBS) controls, respectively, were applied (3 tissues per group). The tissues were incubated at room temperature for 25 minutes and in the incubator for 35 minutes. 1 hour after application, the tissues were washed, dried, and incubated at 37 °C for 24+/-2 hours, followed by a 18+/-2 hours post-incubation period. The medium was then replaced with MTT solution. After 3 hours of incubation, the tissues were washed and incubated with isopropanol to extract the metabolically formed formazan. The optical density at 570 nm was determined spectrophotometrically. Irritant potential was predicted from the mean relative tissue viabilities compared to the negative control. A chemical is considered as "irritant", if the mean relative tissue viability is <=50%. The tissues treated with the test substance showed a mean relative viability of 99%. Based on these results, it can be concluded that under the test conditions chosen, Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] is not irritating in the EpiDerm skin irritation test.