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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD Guideline n° 404 and in compliance with UK GLP standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
reaction mass of calcium sulfate,magnesium dihydroxide,calcium carbonate
IUPAC Name:
reaction mass of calcium sulfate,magnesium dihydroxide,calcium carbonate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The test material was moistened with 0.5 ml of distilled water
Controls:
not required
Amount / concentration applied:
A quantity of 0.5g of the test material was applied
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
no data
Irritant / corrosive response data:
The substance is classified as non-irritant and non-corrosive.

Applicant's summary and conclusion

Conclusions:
The test substance did not result in skin irritation. Therefore the substance should not be classified for skin irritation/corrosion using the criteria of Directive 67/548/EEC (DSD) or the criteria of Regulation No 1272/2008 (CLP).