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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
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 (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

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:
Black powder, Lot No. Composite 01, Composition : 2% Ti3O5, 49% Ti4O7, 36% Ti5O9, 5% Ti6O11, 8% Ti7O13. 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.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
The animals were in the weight range 301-343 g on arrival and approximately 4-5 weeks of age. They were acclimatised for 12 days prior to starting the experiment. The animals were in the weight range 411-507 g at the start of the experiment. The control group was 5 animals and the test group 10 animals. A vitamin C enriched guinea-pig diet FD1 and drinking water were provided ad libitum. Room temperature was maintained at approximately 21 Centigrade and relative humidity at 30-70% and 12 hours artificial light per day.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
coconut oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
Induction intradermal injection: 10% w/v in Alembicol D

Induction topical application: 60% w/v in Alembicol D

Concentration of test material and vehicle used for each challenge:
60 and 30% w/v in Alembicol D
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
coconut oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
Induction intradermal injection: 10% w/v in Alembicol D

Induction topical application: 60% w/v in Alembicol D

Concentration of test material and vehicle used for each challenge:
60 and 30% w/v in Alembicol D
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Induction intradermal injections (test animals) - a 40x60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20x40 mm area within the clipped area. lnjectables for the test animals were prepared as follows:lnjectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an volume of water for irrigation
2. Ebonex Powder, 10% w/v in Alembicol D.
3. Ebonex Powder, 10% w/v in a 50 ; 50 mixture of Freund's complete adjuvant and Alembicol D.

Induction topical application - test animals
The preliminary investigations indicated that the maximum practical concentration of the test substance for topical application (60%) did not produce skin irritation. Therefore, six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 05 mI per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 X 4() mm patch of Whatman No. 3 paper was saturated with approximately 0.4 m1 of Ebonex Powder, 60% w/v in Alembicol D. The patch was placed on the skin of the test animal,; and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm)~ This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.

Induction - control animals
During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
Challenge controls:
The control and test animals were challenged topically two weeks after the topical induction application using Ebonex Powder, 60 nad 30 % in Alembicol D.
Positive control substance(s):
yes
Remarks:
hexyl cinnamic aldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 60 %

Signs of irritation during induction:
Slight irritation was seen in test animals receiving Ebonex
Powder, 10% w/v in Alembicol D and slight irritation was
observed in control animals receiving Alembicol D alone.

Evidence of sensitisation of each challenge concentration:
None

Other observations:
None

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The test substance did not produce eveidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
Executive summary:

The skin sensitisation potential of the test substance was determined in the guinea-pig (10 test animals, 5 controls). the following dose levels were used: Intradermal injection, 10% w/v in Alembicol D; Topical application, 60% w/v in Alembicol D and Challenge application, 60 and 30% w/v in Alembicol D. The test substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.