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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study

Data source

Reference
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 1997, LLNA had not been available yet.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
> 98%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
Pirbright-White guinea pig / female
HsdPoc:DH
HARLAN WINKELMANN
Gartenstr. 27
D-33178 Borchen
SPF breeding colony
Body weight at start of study
mean = 368 g (= 100 %)
min = 335 g (- 9.0 %)
max = 403 g (+ 9.5 %)
n = 15
fur marking with KMn04 and cage numbering

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Oleum sesami DAB 10
Concentration / amount:
Concentration of test material and vehicle used at induction:
intradermal: 2 % Oleum sesami DAB 10
dermal: 25 % in Oleum sesami DAB 10
Concentration of test material and vehicle used for each challenge:
25 % in Oleum sesami DAB 10
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Oleum sesami DAB 10
Concentration / amount:
Concentration of test material and vehicle used at induction:
intradermal: 2 % Oleum sesami DAB 10
dermal: 25 % in Oleum sesami DAB 10
Concentration of test material and vehicle used for each challenge:
25 % in Oleum sesami DAB 10
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Treatment group
1.) 50 % Freund's Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed
immediately before use with an equal volume of deionized water.
2.) 2 % Beta W 7 A 1.0 in Sesame oil (Oleum sesami DAB 10)
3.) 2 % Beta W 7 A 1.0 in a 50 % Freund's Complete Adjuvant emulsion
For the intradermal injections of the test substance in 50 % Freund's adjuvant, Beta W
7 A 1.0 was dissolved in Freund's Original Adjuvant and then mixed with an equal
volume of deionized water [percentages w/v].
For the dermal treatments, Beta W 7 A 1.0 was suspended in Sesame oil
[percentages w/v].

An amount of 0.5 ml of the test substance preparation (treatment group)
or the vehicle (control group) was administered to a 2 x 4 cm cellulose
patch, This patch covered the area where the intradermal injection had
been placed. The administration area was then kept for 48 hours under
an occlusive bandage with an impermeable film and an elastic bandage.
Treatment group 25.0 % test substance in sesame oil
Control group sesame oil
Occlusive bandage removed, irritant effects recorded.
No treatment of control or treatment group.
Test animals kept under observation.
Challenge controls:
Control group
1.) 50 % Freund's Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed
immediately before use with an equal volume of deionized water.
2.) Sesame oil (Oleum sesami DAB 10)
3.) 50 % Freund's Complete Adjuvant emulsion mixed with an equal volume of the
vehicle
Positive control substance(s):
yes
Remarks:
Benzocain

Results and discussion

Positive control results:
The validity of the test system is confirmed by the periodically conducted positive
control test using benzocain for the maximization test (report number 97.0326, dated
June 02, 1997; Hoechst Marion Roussel, Preclinical Development Germany, Drug
Safety).



In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Intradermal induction treatment

Two intradermal injections per animal of the following preparations. The

injection sites (site 1, 2 and 3) were all within a dorsal area of 2 x 4 cm

(see prior page). The injection sites were left uncovered.

Dermal induction treatment

An amount of 0.5 ml of the test substance preparation (treatment group)

or the vehicle (control group) was administered to a 2 x 4 cm cellulose

patch, This patch covered the area where the intradermal injection had

been placed. The administration area was then kept for 48 hours under

an occlusive bandage with an impermeable film and an elastic bandage.

Dermal challenge treatment

One area of approx. 5 x 5 cm on the left flank was shaved mechanically.

An amount of 0.5 ml of the test substance preparation was administered

to a 2 x 2 cm cellulose patch. The administration area was then kept for

24 hours under an occlusive bandage with an impermeable film and an

elastic bandage.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Based on the results of an OECD 406 study (GM Beta W 7 A 1.0 showed no evidence for sensitizing properties.
Executive summary:

Under the conditions of the present study, none of ten animals of the treatment group

showed a positive skin response after the challenge procedure.

Thus, the percentage of animals reacting positive is below the threshold of 30 %.

Based on the results of this study Beta W 7 A 1.0 showed no evidence for sensitizing

properties.