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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no data about purity of test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Principles of method if other than guideline:
In vitro skin irritation examined by HUMAN SKIN MODEL TEST according to the method B.46 ANNEX III (Regulation REACH 1907/2006)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BATCH: N2B
DATE OF PRODUCTION: 04.11.2008
no further details

Test animals

Species:
other: in vitro

Test system

Type of coverage:
other: in vitro
Vehicle:
water
Controls:
other: positive (5 % sodium dodecyl sulfate) and negative (physiol. saline) controls
Amount / concentration applied:
25 mg per tissue insert solved in 25 µL water
Duration of treatment / exposure:
1 h
Observation period:
42 h postincubation plus 3 h MTT medium
Number of animals:
tested on three tissues

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Remarks: irritant. (migrated information)

Any other information on results incl. tables

Optical density (no data about units): 2.43 in negative control, 0.21 in positive control and 0.21 after treatment with the test substance.

Cell viability: 100% in negative control, 8.8 in positive control and 8.6 after treatment with the test substance.

Viability <50% after 1 h exposure corresponds to irritant properties.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Skin irritant properties have been shown in In vitro skin irritation examined by HUMAN SKIN MODEL TEST according to the method B.46 ANNEX III (Regulation REACH 1907/2006). However, no discrimination between corrosive and irritant properties is possible with this test system.