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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Dec 2017- 04 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
28 July 2015
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide
EC Number:
947-922-8
Molecular formula:
n.a. (UVCB)
IUPAC Name:
Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide
Test material form:
liquid
Details on test material:
clear yellowish liquid

In vitro test system

Test system:
human skin model
Remarks:
EPI-200-SIT
Justification for test system used:
Recommended in vitro model
Details on test system:
Dose Groups
1. Negative control 30 µL DPBS
2. Positive control 30 µL 5% SDS solution
3. Test Item 30 µL
The test was performed on a total of 3 tissues per dose group.
SDS sodium dodecyl sulfate
DPBS Dulbecco's phosphate buffered saline
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
30 µL Test item
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
47 hours
Number of replicates:
3

Test system

Details on study design:
The test was performed on EpiSkin,a three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test
item, the negative control (30 µL DPBS) and the positive control (300µL 5% SDS), respectively. After 60 minutes treatment period at room temperature the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 47 h (based on RhE model). Then the tissues are stained via MTT for 3 hours. The MTT was extracted from the tissues for 2 hours at room temperature with gentle shaking on a plate shaker. MTT extracts are measured photometrically at 570 nm.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
negative control
Value:
>= 96.1 - < 102.6
Negative controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
positive control
Value:
>= 4.7 - < 4.9
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item
Value:
>= 7.2 - < 7.8
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the results obtained under the laboratory testing conditions, the test item has been categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS Category 2 or Category 1, as the mean percentage after 60 minutes of exposure and 45 hours and 10 minute post incubation, tissue viability was less than 50% of the negative control.
Executive summary:

The skin irritation potential of the submission study was evaluated using Reconstructed Human Epidermal Model - EpiDerm (EPI-200 -SIT) according to OECD Guideline 439.

Based on the results obtained under the laboratory testing conditions, the test item has been categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS Category 2 or Category 1, as the mean percentage after 60 minutes of exposure and 45 hours and 10 minute post incubation, tissue viability was less than 50% of the negative control.