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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-02-06 to 1995-02-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals (3) were in the weight range 2.6-2.8 Kg and approximately 11-12 weeks old prior to treatment. Standard laboratory diet and drinking water were provided ad libitum. Room temperature was 19C and 12 hours artificial light provided and animals were individually housed.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contalateral eye was untreated
Amount / concentration applied:
100 MG
Duration of treatment / exposure:
single installation, observations made at 1 hour and 1, 2, 3, 4 and 7 days after exposure.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Ebonex Powder elicited dulling of the cornea and well- defined conjunctival irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
A single instillation of 100 mg of the test substance into the eye of the rabbit elicited dulling of the cornea and well- defined conjunctival irritation There were no signs of toxicity or ill health in any rabbit during the observation period and all reactions had resolved seven days after instillation.
Executive summary:

A single instillation of 100 mg of the test substance into the eyes of three rabbits elicited dulling of the cornea and well- defined conjunctival irritation There were no signs of toxicity or ill health in any rabbit during the observation period and all reactions had resolved seven days after instillation.