Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
other: in vitro (Epiderm)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EU Method b.46 (Skin Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, reaction products with diethanolamine
EC Number:
293-014-3
EC Name:
Fatty acids, C16-18, reaction products with diethanolamine
Cas Number:
91032-08-5
Molecular formula:
C22H45NO3 to C52H101NO5
IUPAC Name:
Fatty acids, C16-18, reaction products with diethanolamine

Test animals

Species:
other: EpiDerm reconstructed human epidermis model (MatTek Corp.)
Details on test animals or test system and environmental conditions:
organotypic reconstructed three-dimensional model of the human epidermis

Test system

Type of coverage:
other: direct application
Controls:
other: three tissues for negative control (30µL DPBS) and positive control (30µL 5% SDS)
Amount / concentration applied:
solids: 25 µL DPBS + 25 mg
Duration of treatment / exposure:
60 +/- 1 minutes
Observation period:
42 +/- 4 h
Number of animals:
three replicate tissues per dose group
Details on study design:
3 replicate tissues are dosed with the test item, the negative control (DPBS) and the positive control (5% SDS), respectively. The tissues are incubated for 35 +/-1 minutes in a humidified incubator (37+/- 1 °C, 5 +/- 1% CO2, 95% RH) and further 25 minutes at room temperature. Then the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 24 +/- 2 h and, after medium renewal, for further 18 +/- 2 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: mean relative tissue viability
Basis:
other: mean tissue viability of the negative control tissues
Time point:
other: 60 min treatment 42 h post-incubation
Score:
> 50
Remarks on result:
other: non-irritant; EU CLP and UN GHS: No Category
Irritation parameter:
other: mean relative tissue viability
Basis:
other: mean tissue viability of the negative control tissues
Time point:
other: 60 min treatment 42 h post-incubation
Score:
<= 50
Remarks on result:
other: irritant; EU CLP and UN GHS Category 2
Irritant / corrosive response data:
If mean tissue viability is > 50% relative to the mean negative control, the test item is classified as non-irritant (EU CLP and UN GHS: No Category).
If mean tissue viability is =< 50% relative to the mean negative control, the test item is classified as irritant (EU CLP and UN GHS: Category 2).
Other effects:
The test item showed no direct MTT reducing capability and no colouring potential.

Any other information on results incl. tables

Name

NC

PC

TM

Tissue

1

2

3

1

2

3

1

2

3

OD550(blank-corrected)

1.320

2.141

1.843

0.123

0.117

0.117

1.961

2.564

2.449

1.626

1.912

1.814

0.137

0.089

0.121

2.566

2.601

2.443

mean OD550of the replicates (blank-corrected)

1.473

2.026

1.828

0.130

0.103

0.119

2.263

2.582

2.446

total mean OD550of 3 replicate tissues (blank-corrected)

1.776

0.117

2.430

SD OD550

 

0.279

 

 

0.016

 

 

0.239

 

relative tissue viability [%]

82.9

114.1

103.0

7.3

5.8

6.7

127.5

145.4

137.7

SD tissue viability [%]***

15.8

0.8

9.0

CV [% viability]

 

15.8

 

 

11.5

 

 

6.6

 

mean relative tissue viability [%]

100.0

6.6

136.9

*          Corrected mean OD550of the negative control corresponds to 100% absolute tissue viability.

**      mean relative tissue viability of the three positive control tissues is < 20%

***     standard deviation (SD) obtained from the three concurrently tested tissues is 18%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is classified as "non-irritant" (EU CLP and UN GHS: No Category).
Executive summary:

In the in vitro skin irritation test using the EpiDerm human epidermis model 25 mg test item + 25 µL DPBS were applied topically for 60 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.

The test item showed no irritant effects. The mean relative tissue viability (% negative control) was> 50% (137%) after 60 min treatment and 42 h post incubation.

This study is classified as acceptable:

Mean OD550 of the three negative control tissues is >=1 and <=2.5.

Mean relative tissue viability of the three positive control tissues is <= 20%.

Standard deviation (SD) of relative tissue viablity obtained from each three concurrently tested tissues is < 18%.

This study satisfies the requirement for Test Guideline OECD 439 for in vitro skin irritation.