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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. The study is a read across from tetradecanol (CAS 112-72-1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(based on)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Tetradecanol
EC Number:
204-000-3
EC Name:
Tetradecanol
Cas Number:
112-72-1
IUPAC Name:
112-72-1
Constituent 2
Reference substance name:
tetradecanol
IUPAC Name:
tetradecanol
Details on test material:
Tradename Lorol 14-98, MV626

Test animals

Species:
human
Strain:
other: n/a
Details on test animals or test system and environmental conditions:
Age of the subjects was 22 - 53 years with an average of 34.9 years. 

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application.
Number of animals:
20
Details on study design:
15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of 
healthy volunteers.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritant / corrosive response data:
No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Lorol C12-98 is not irritating to human skin following a 4 hour semi-occlusive exposure. The study was conducted accordint to GLP. The result is a read across from tetradecanol (CAS 112-72-1).