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Administrative data

Description of key information

Two GLP, Guideline in vitro tests were performed in order to assess the skin corrosive/irritating potential of LAS IPA. The results show that the substance is not corrosive to the skin, but it does have irritating properties. One GLP in vitro eye irritation test suggests that the substance is irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
16 to 18 October 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, no specific guideline followed (no guideline available for this test)
Qualifier:
no guideline available
Principles of method if other than guideline:
The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death. Cytotoxicity is measured with the MTT reduction assay.
GLP compliance:
yes (incl. QA statement)
Species:
other: not applicable
Details on test animals or tissues and environmental conditions:
SkinEthic reconstructed Human Corneal Epithelium model (HCE, SkinEthic Laboratories, Lyon, France)
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
see below details on study design
details on negative control (Solution A); compostition for 1 L: Na2HPO4 0.142 g/l, glucose 1.802 g/l, HEPES 7.149 g/l, KCl 0.224 g/l and NaCl 7.597 g/l
positive control: sodium dodecyl sulphate (SDS) 2% w/v
Details on study design:
Pre-test: Test MTT reduction by the test material: 30 ul test material + 1 ml 0.5 mg/ml MTT solution incubated for 3 h. The blue colour indicates reduced MTT.
MAIN TEST
7-day old tissues were transferred into wells and treated with 30 ul test item
Exposure period: 10 min
Negative control: 30 ul solution A
Positive control: 30 ul of 2% w/v SDS
Washing: DPBS without Ca++ and Mg++
Placement of each tissue into a 24-well plate with 300 ul maintenance medium
MTT loading plates: 300 ul of a 0.5 mg/ml MTT solution
Incubation: 3 hours
Washing: phosphate buffered saline
Isopropanol was applied for the formation of formazan crystals
Optical density (OD) was measured at 540 nm with Anthos 2001 microplate reader

Tissue histopathology: one tissue/treatment group was kept for histopathological examination
Remarks on result:
other: not applicable, see below
Irritant / corrosive response data:
see below in section 'Any other information on results incl. tables'
Other effects:
The MTT solution conatining the test item did not turn blue, suggesting that the test material does not reduce directly MTT.

Table 1: Assessment of Eye Irritation Potential- Viability of HCE tissues

Item

OD540of Individual Tissue

Mean OD540

Relative Mean Viability (%)

Negative Control

0.965

0.926

100

0.887

Positive Control

0.022

0.022

2.4

0.021

Test item

0.141

0.154

16.6

0.167

 

Tissue histopathological examination was not performed cause it was not considered necessary.

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: criteria of the test
Conclusions:
Based on the results of the study, BIO-SOFT 411-E and hence, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1), are both eye irritants.
Executive summary:

The purpose of this study was to determine the eye irritation potential of BIO-SOFT 411 -E using the SkinEthic reconstructed Human Corneal Epithelium model (HCE, SkinEthic Laboratories, Lyon, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death. Cytotoxicity is measured with the MTT reduction assay.

Triplicate tissues were exposed to the test material and thereafter, to MTT. The optical density was measured at 540 nm.Data were presented in the form of percentage viability (MTT conversion relative to negative controls).The relative mean viability of the test item treated tissues after a 10 min exposure period was 16.6 %, i.e. the test the test item is an eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The potential skin effects of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (97%) were tested in two in vitro studies with the use of reconstructed human epidermis models (EPISKINTM). The principle of the assays is based on the measurement of cytotoxicity in the human epidermal cultures following topical exposure to the test material, with the MTT reduction assay. The in vitro test for skin corrosion gave a negative result, while the in vitro test for skin irritation suggests that the substance has skin irritating properties.

Eye irritation

An in vitro eye irritation test was performed with the use of the SkinEthic Human Corneal Epithelium model in order to examine the eye irritation potential of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (97%). The results showed a relative mean viability of the test item treated tissues after a 10 min exposure period of 16.6 %, i.e. the test the test item shall be considered an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The weight of evidence approach was applied to address the endpoint of skin irritation, since no single study available can address this requirement.

Justification for selection of eye irritation endpoint:
Only available study.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the classification criteria laid down in Regulation (EC) No 1272/2008 benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (LAS IPA) shall be classified and labeled as irritating to the skin (Skin Irrit. 2, H315) and eye (Eye Irrit. 2, H319).