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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Direct Brown 44
Direct Brown 44

Test animals

other: Control tissue
not specified

Test system

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

Results and discussion

In vitro

Irritation / corrosion parameter:
other: other: % of killed tissue
ca. 0
Remarks on result:
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
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.