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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:
1990-05-30 to 1990-10-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Principles of method if other than guideline:
Summary of protocol amendments:
The challenge skin reactions with score 1 or more were considered to be a sign of sensitization, instead of challenge skin reactions with score 2 or more as noted in the protocol. This change in normal evaluation procedure was implemented as a result of the clear difference i n response between control and experimental animals.
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
Milli-Q water
Concentration / amount:
Induction phase:
Experimental animals were exposed on day 1 with 0.5 ml of the test substance suspended to 50 % (wlw) in milli-RO water. From day 3 onwards, the test substance concentration was decreased to 25 % ( w /w ) , since the 50 % was too viscous.
Challange expoure:
Concentration of test material and vehicle used for 1st. challenge: 25%
Rechallenge: 25%, 10%, 5% (w/w) in Milli-Ro water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
Milli-Q water
Concentration / amount:
Induction phase:
Experimental animals were exposed on day 1 with 0.5 ml of the test substance suspended to 50 % (wlw) in milli-RO water. From day 3 onwards, the test substance concentration was decreased to 25 % ( w /w ) , since the 50 % was too viscous.
Challange expoure:
Concentration of test material and vehicle used for 1st. challenge: 25%
Rechallenge: 25%, 10%, 5% (w/w) in Milli-Ro water
No. of animals per dose:
Number of animals in test group: 20 Number of animals in negative control group: 10
Challenge controls:
The challenge sites of experimental and control animals were assessed for redness and swelling 24 and 48 hours after removal of the dressings.
Positive control substance(s):
yes
Remarks:
formaldehyde

Results and discussion

Positive control results:
Clearly positive results were observed in the experimental animals after the challenge with 0.5% (w/w) FORMALDEHYDE in milli-RO water. experiment carried out once a year.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25 %
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
Very small crusts.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: Very small crusts..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 %
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
Very small crusts. Oedema under crusts, no erythema observed.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: Very small crusts. Oedema under crusts, no erythema observed..
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
25 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Very small crusts and swelling underneath, no erythema observed.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Very small crusts and swelling underneath, no erythema observed..
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
25 %
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Very small crusts and swelling underneath, no erythema observed.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Very small crusts and swelling underneath, no erythema observed..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
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: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
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: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
A 25 % solution of the substance resulted in a sensitization rate of 20 % in guinea pig. The substance therefore should be labelled as a skin sensitizer.