Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(based on)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
human
Strain:
other: n/a
Details on test animals 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:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: n/a
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
GHS criteria not met
Conclusions:
Lorol C12-98 is not irritating to human skin following a 4 hour semi-occlusive exposure. The study was conducted accordint to GLP.
Executive summary:

In the skin irritation study, undiluted test material was applied onto human skin and kept in contact to the skin under semi-occlusive dressing for 4 hours. Erythema and oedema scores were recorded at 1, 24, 48 and 72 hours after application.

No erythema and oedema were observed during the study period.