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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1995-01-31 to 1995-02-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although this was a GLP Study, the copy of the report used to prepare this Robust Study Summary was incomplete and was missing the title page and page 10 which contained the experimental details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
92/69/EEC
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
416-390-4
EC Name:
-
IUPAC Name:
Blend of Magneli suboxides of titanium
Details on test material:
Nature of substance: Solid, Lot No. Composite 01, Composition : 2% Ti3O5, 49% Ti4O7, 36% Ti5O9, 5% Ti6O11, 7% Ti7O13, 1% Ti8O15. The Ebonex Powder used in this experiment differed from the Substance listed in Section 1 in that it contained less Ti4O7 and Ti6O11 and more Ti5O9. It also contained small proportions of Ti3O5, Ti7O13 and Ti8O15. However, the Ebonex Powder used for this study was still a blend of Magneli suboxides of titanium, primarily based upon the same three titanium oxides, Ti4O7, Ti5O9 and Ti6O11 as in the current Ebonex Powder listed in Section 1. As such the results from the Ebonex Powder used in this experiment are considered to be applicable for the current Ebonex Powder as listed in Section 1.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The animals (3) were in the weight range 2.4-2.6 Kg and approximately 11 weeks old prior to treatment. Standard laboratory diet and drinking water were provided ad libitum. Room temperature was 19 Centigrade, 30-70% relative humidity and 12 hours artificial light provided and animals were individually housed.

Test system

Type of coverage:
semiocclusive
Vehicle:
other: The test substance was administered as supplied.
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
1, 2, 3 and 4 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Other effects:
None

Any other information on results incl. tables

No dermal response to treatment was observed in any animal throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No dermal response to treatment was observed in any animal throughout the observation period.
Executive summary:

Three rabbits were each administered a single dermal dose of 0.5g of the test substance and the dose site semi-occluded for 4 hours. The animals were observed for four days after application. No dermal response following a semi-occlusive application of the test substance to intact skin was observed in any animal throughout the observation period.