Amides, tall-oil fatty, N,N'-(iminodi-2,1-ethanediyl)bis-, maleated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17-07-2013 to 18-07-2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: not formally validated study method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Principles of method if other than guideline:

The SkinEthic reconstructed human corneal epithelium assay is used

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2Z)-3-({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl}({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl)prop-2-enoic acid; (2Z)-3-[bis({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl})carbamoyl]prop-2-enoic acid; (2Z)-3-[bis({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl]prop-2-enoic acid

EC Number:

800-430-6

Cas Number:

1419212-76-2

Molecular formula:

ca. C44H75N3O5 - C48H81N305

IUPAC Name:

(2Z)-3-({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl}({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl)prop-2-enoic acid; (2Z)-3-[bis({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl})carbamoyl]prop-2-enoic acid; (2Z)-3-[bis({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl]prop-2-enoic acid

Test material form:

other: gel

Details on test material:

- Substance type: UVCB
- Physical state: paste
- Purity: 100% (UVCB)
- Storage condition of test material: room temperature in dark

Test system

Details on study design:

The SkinEthic reconstructed human corneal epithelium assay uses corneal epithelial tissue to assess penetration and concomittant cytotoxicity of the test substance.

In a pre-test direct interaction of the test substance with the detection chemical MTT is assessed.
In the main study triplicate SkinEthic tissues were treated with 30 uL of the test substance during 10 minutes. In addition a negative control (Na2HPO4 0.142 g/L; glucose 1.802 g/L; HEPES 7,149 g/L; KCl 0.224 g/L; NaCl 7.597 g/L) and a positive control (2% SDS) were included. After treatment tissues (3 per treatment) were rinsed and treated with MTT. Optical density of extracted MTT solutions was measured at 562 nm. Viability was expressed as percentage MTT conversion versus negative control.
Tissue viability ≥ 60% means non-irritant
Tissue viability < 60% means irritant

Results and discussion

In vitro

Results

Irritation parameter:

other: % tissue viability

Value:

89.4

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

6.7% rel viability

In vivo

Other effects:

The test substance did not interfere with the reduction of MTT to blue formazan salt.

Any other information on results incl. tables

	Mean OD562	Relative mean viability
Negative control:	0.940	100%
Test substance:	0.840	89.4%
SDS:	0.063	6.7%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is non-irritant in the SkinEthic reconstructed human corneal epithelium assay.
Criteria used for interpretation of results: other: < 60% viability is indicative for positive result

Executive summary:

In this assay triplicate SkinEthic tissues were treated with 30 uL of the test substance during 10 minutes. After treatment tissues were rinsed and treated with MTT. Optical density of extracted MTT solutions was measured at 562 nm. Viability was expressed as percentage MTT conversion versus negative control. The viability was 89.4%, which is indicative for non-irritant substances.

As the assay is not formally validated, the results need to be regarded as preliminary.