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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant OECD 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:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
(2004)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
(2010)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht

Test material

Constituent 1
Reference substance name:
70955-07-6
EC Number:
615-218-7
Cas Number:
70955-07-6
IUPAC Name:
70955-07-6
Details on test material:
- Name of test material (as cited in study report): Alcohols, tallow, propoxylated (>1 < 2.5 mol PO)
Peroxylation gradde: < 2.5
- Physical state: Liquid
- Analytical purity: 96.6%
- Batch No.: CP11090009
- Stability under test conditions: Guaranteed by the sponsor

Test animals

Species:
human
Strain:
other: EpiDerm™ 200 kit (MatTek In Vitro Life Science Laboratories)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 50 µL de-ionized water (corrosion test); 30 µL PBS (irritation test)
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: 50 µL (corrosion test), 30 µL (irritation test) of the undiluted test substance
Duration of treatment / exposure:
for 3 min and 1 h (corrosion test); 1 h (irritation test)
Observation period:
None (corrosion test), 42 h post-incubation period (irritation test)
Number of animals:
corrosion test: 2 inserts per period of incubation time and treatment group (test material, negative control and positive control)
irritation test: 3 inserts per period of incubation time andtreatment group (test material, negative control and positive control)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: viability (in % of control)
Basis:
mean
Time point:
other: 3 min (corrosion test)
Score:
100
Remarks on result:
other: A test substance is considered corrosive if the cell viability is below 50% after 3 min exposure period.
Irritation parameter:
other: viability (in % of control)
Basis:
mean
Time point:
other: 60 min (corrosion test)
Score:
108
Remarks on result:
other: A test substance is considered corrosive if the cell viability is below 15% after 60 min exposure period.
Irritation parameter:
other: viability (in % of control)
Basis:
mean
Time point:
other: 60 min (irritation test)
Score:
121
Remarks on result:
other: A test substance is considered irritating if the cell viability is less than or equal to 50% after 60 min exposure and a subsequent 42 h post incubation period.

Any other information on results incl. tables

The test substance did not directly reduce MTT as examined in a pre-experiment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not irritating
DSD: not irritating