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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19.06.2018 - 09.08.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
Adopted 29. July 2016
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
EC Number:
294-347-7
EC Name:
Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
Cas Number:
91697-85-7
Molecular formula:
Not available
IUPAC Name:
Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
Test material form:
solid: bulk

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: Human-derived epidermal keratinocytes
Cell source:
other: Multilayered, highly differentiated model of the human epidermis, EpiDerm Skin Model
Source strain:
other: EPI-200, Lot no.: 28811, kit L and M (see appendix 4)
Justification for test system used:
Recommended test system in international guidelines (OECD and EC).
Vehicle:
other:
Details on test system:
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50.3, 56.8 mg
Duration of treatment / exposure:
3 minutes
Duration of post-treatment incubation (if applicable):
1 hour
Number of replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Remarks:
3-minute application
Run / experiment:
4
Value:
>= 103 - <= 103
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
1-hour application
Run / experiment:
4
Value:
>= 103 - <= 103
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Executive summary:

In conclusion, 35730 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report (OECD 431).