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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed in accordance with GLP and following OECD guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Setafix X11342
IUPAC Name:
Setafix X11342
Test material form:
solid: crystalline
Details on test material:
Yellowish Solid
Batch: PP02
Purity: +/- 95%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 animals of one sex were used.
Animals used within the study were at least 6 weeks old and body weights were between 1.0 and 3.5Kg.
Identification: Earmark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
Test substance was ground to a powder usign a pestle and mortar prior to weighing and the test substance was moistened with 0.4ml water (Mill-U) immediately before application to ensure close contact with the animals skin.
0.5g of test substance was applied.
Duration of treatment / exposure:
Four hours after the application of test substance, the dressing was removed and the skin cleaned of residual test substance using water.
Observation period:
Mortality / Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application).
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
Number of animals:
3 animals of one sex.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Animal #925
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Animal #926
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Animal #927
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Animal #925
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Animal #926
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Animal #927
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to SETAFIX X 11342

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Guideline in commission Directive 93/21/EEC
Conclusions:
No skin irritation was caused by 4 hours exposure to SETAFIX X 11342.
Executive summary:

No skin irritation was caused by 4 hours exposure to SETAFIX X 11342