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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

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

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 404
Principles of method if other than guideline:
Method: other: patch test based on OECD 404
The effect on human skin was investigated:
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. Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application. 20 male and female volunteers were tested.
Age was 22 - 53 years with an average of 34.9 years.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14
EC Number:
279-420-3
EC Name:
Alcohols, C12-14
Cas Number:
80206-82-2
Molecular formula:
C13H28O
IUPAC Name:
Alcohols, C12-14
Details on test material:
Tradename Lorol Spezial C12-14 alcohols Type AType A. 100% Linear; >90% C12/14 (C12>14), <10% C16 [range C6-C18];

Method

Type of population:
general
Subjects:
20 male and female volunteers were tested. Age was 22 - 53 years with an average of 34.9 years.
Ethical approval:
confirmed, but no further information available
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
estimated
Details on exposure:
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. Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application. 20 male and female volunteers were tested. Age was 22 - 53 years with an average of 34.9 years.
2-3 drops of the test material or a dilution were applied to the dorsal skin as follows:
-100% and 50% twice daily for 4 days (8 applications)
-25% and 10% twice daily for 10 days (20 applications)

Results and discussion

Clinical signs:
Result: No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
Results of examinations:
Result: No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).

Applicant's summary and conclusion

Conclusions:
Result: No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
Alcohols, C12-14 is not irritating to human skin following a 4 hour semi-occlusive exposure.