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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
April 28,2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP compliant, summary report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
corrosive test in vitro
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Control tissue
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
1 hour
Details on study design:
SCORING SYSTEM: % of killed tissue

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: % of killed tissue
Value:
ca. 0
Remarks on result:
other:
Remarks:
Basis: other: in vitro test. Time point: 1 hour. Max. score: 100.0. (migrated information)

Any other information on results incl. tables

Exposure 3 minutes
optical density
test article tissue 1 tissue 2 KC mean Optical density mean Optical density KC corrected Viability(% of NC)
NC 2.105 2.057 0.245 2.083 - 100
03/0250-2 2.354 2.244 0.265 2.299 - 110
PC_C 0.351 0.32 - 0.335 - 16

Exposure 1 hour
optical density
test article tissue 1 tissue 2 KC mean Optical density mean Optical density KC corrected Viability(% of NC)
NC 1.925 2.13 0.184 2.028 - 100
03/0250-2 2.49 1.913 0.223 2.202 - 108
PC_C 0.196 0.196 - 0.198 - 10

NC: negative control

PC_C: positive control

KC: killed tissue control

Applicant's summary and conclusion

Interpretation of results:
other: non corrosive under Regulation 1272/2008
Conclusions:
Evaluation: non corrosive
Executive summary:

An in vitro study using the EpiDerm TM human skin model showed the non-corrosivity of the substance. In order to further assess the acute skin Irritation potential of the test substance a dermal irritation/corrosion test in White New Zealand rabbits was performed according to the method described in OECD guideline 404.