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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
20 December 1989 to 31 January 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
432-240-0
EC Name:
-
Cas Number:
12056-51-8
Molecular formula:
K2Ti6O13
IUPAC Name:
hydrate potassium hydride titanium

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
other: The test material as supplied was moistened with 0.5 mL of distilled water.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 hours
Number of animals:
6 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period:
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
Slight erythema (score 1) was observed in 3 out of 6 animals at 1 hour only.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was concluded to be not irritating to the skin.
Executive summary:

The skin irritation potential of the test material was investigated in a study which was conducted under GLP conditions.

During the study the skin of 6 New Zealand White rabbits was exposed to 500 mg of test material moistened with 0.5 mL of distilled water, under occlusion, for a period of 4 hours.

Slight erythema (score 1) was observed in 3 out of 6 animals; all changes were fully reversible within 1 day.

Therefore, under the conditions of the study, the test material was concluded to be not irritating to the skin.