Tall-oil fatty acids oligomeric reaction products with triethylenetriamine and gylcidyl tolyl ether

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Due to corrosive nature of the substance acute inhalation testing is not required

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

18 September 2012 to 25 March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Fully GLP compliant and in accordance with current test guidelines

Justification for type of information:

Please refer to the read across justification document enclosed in chapter 13 for details

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes

Species:

other: Not applicable

Strain:

other: Not applicable

Details on test animals or test system and environmental conditions:

Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum supplied by MatTek Corporation, Ashland, Massachusetts, USA. Human keratinocytes are used to construct the epithelium. Multiple layers of viable epithelial cells are present under a functional stratum corneum. The stratum corneum is multi-layered with the necessary lipid profile to produce a functional barrier. The containment properties of the model prevent the passage of material around the stratum corneum to the viable model tissue. The skin model was supplied free of contamination with bacteria, mycoplasma and fungi.

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Three tissues per test article, negative control and positive control were treated by application of 30 µL of the negative control, 30 µL of the positive control and approximately 70 mg of test article onto the surface of the tissues.

Details on study design:

The tissues were incubated at 37 ± 1ºC, 5 ± 1% Carbon Dioxide for a 35 ± 1 minute period. The plates were then removed from the incubator and placed into a sterile hood until the 60 minute treatment period was complete for each tissue.
Following treatment, substances were removed by washing the tissues. The tissues were then placed on the appropriate medium and incubated for 42 hours. The protocol stated that the incubation period would be 24 hours. This deviation from protocol was considered not to have affected the integrity or outcome of the study as this was an error in the protocol and the correct incubation period was used for this test system.
To evaluate whether residual test article was binding to the tissue, a functional check (using freeze-killed control tissue) was performed. Freeze-killed tissues were prepared by placing untreated EpiDerm constructs in the -20°C freezer overnight. The freeze-killed tissues were allowed to thaw once at room temperature and placed back in the freezer until required.

Irritation / corrosion parameter:

other: other: relative group mean viability

Value:

7.2

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 60 minutes treatment period. Max. score: 100.0. Reversibility: no data. (migrated information)

Irritant / corrosive response data:

The relative group mean viability for the test article was 7.2%.
The relative group mean viability for the positive control was 4.9%.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

The test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, was considered not to be corrosive to the in vitro skin model EpiDermTM, but was considered to be an irritant to the in vitro skin model EpiDermTM SIT (EPI-200).

Executive summary:

The purpose of the study was to determine whether the test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, caused dermal corrosion or irritation. Dermal corrosion refers to the production of irreversible tissue damage in the skin following the application of a test material. Dermal irritation refers to the production of reversible inflammatory changes in the skin following the application of a test material.

An in vitro skin corrosivity assay (EpiDerm^TM) was initially conducted. This demonstrated that the test article did not have the potential to cause corrosion to the skin therefore an in vitro skin irritation assay (EpiDerm^TM SIT (EPI-200)) was conducted.

EpiDerm^TM SIT (EPI-200) inserts were treated with test article, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 60 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment.

The relative group mean viability for the test article was 7.2% and for the positive control was 4.9%.

The test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, was considered not to be corrosive to the in vitro skin model EpiDerm^TM, but was considered to be an irritant to the in vitro skin model EpiDerm^TM SIT (EPI-200).

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

EDA-BADGE-EDA

Cas Number:

854009-15-7

Molecular formula:

C25H40N4O4

IUPAC Name:

EDA-BADGE-EDA

Constituent 2

Reference substance name:

EDA-BADGE-EDA-BADGE-EDA

Molecular formula:

C48H72N6O8

IUPAC Name:

EDA-BADGE-EDA-BADGE-EDA

Constituent 3

Reference substance name:

EDA-BADGE α-glycol

Molecular formula:

C23H34N2O5

IUPAC Name:

EDA-BADGE α-glycol

Constituent 4

Reference substance name:

reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

IUPAC Name:

reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

Constituent 5

Reference substance name:

Unidentified reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

IUPAC Name:

Unidentified reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

Test material form:

liquid: viscous