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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-August-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximization test (GPMT) is already available for preivous regulation. Therefore, LLNA is not conducted.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
5% and 50% reactive red 224 in physiological saline
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
5% and 50% reactive red 224 in physiological saline
No. of animals per dose:
According to the test guidelines the test was started with the minimum number of animals (5 per sex for the test group and 5 of one sex for controls). After the challenge procedure, it was not possible to conclude if the test substance is a sensitiser or not and therefore testing in additional animals was performed to give a total of 20 test and 10 control animals. The initial weight of the animals was between 328 to 404 g.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control group/ vehicle control
Dose level:
0% Direct Red 224
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
occlusive epidermal application
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group/ vehicle control. Dose level: 0% Direct Red 224. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: occlusive epidermal application.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control group/ test article
Dose level:
50% Direct Red 224
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
occlusive dermal application
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group/ test article. Dose level: 50% Direct Red 224. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: occlusive dermal application.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test group/ vehicle control
Dose level:
0% Direct Red 224
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
occlusive epidermal application
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Test group/ vehicle control. Dose level: 0% Direct Red 224. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: occlusive epidermal application.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test group/ test article
Dose level:
50% Direct Red 224
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
occlusive epdermal application. Erythema score 1 in 3 animals and edema score 1 in 1 animal.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Test group/ test article. Dose level: 50% Direct Red 224. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: occlusive epdermal application. Erythema score 1 in 3 animals and edema score 1 in 1 animal..
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control group/ vehicle control
Dose level:
0% Direct Red 224
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
occlusive epidermal application
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Control group/ vehicle control. Dose level: 0% Direct Red 224. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: occlusive epidermal application.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Test group/ vehicle control
Dose level:
50% Direct Red 224
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
occlusive epidermal application
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Test group/ vehicle control. Dose level: 50% Direct Red 224. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: occlusive epidermal application.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Test group/ vehicle control
Dose level:
0% Direct Red 224
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
occlusive epidermal application
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Test group/ vehicle control. Dose level: 0% Direct Red 224. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: occlusive epidermal application.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Test group/ test article
Dose level:
50% Direct Red 224
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
occlusive epidermal application. Erythema score 1 in 3 animals and edema socre 1 in 1 animal.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Test group/ test article. Dose level: 50% Direct Red 224. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: occlusive epidermal application. Erythema score 1 in 3 animals and edema socre 1 in 1 animal..

Observations and records

Induction reactions

The animals were pretreated with 10% sodium-laurylsulfate on day 7.

After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 control and in 20/20 test group animals.

Challenge reactions

Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.

 

Results

The incidence of positive animals per group, the individual challenge reactions and the evaluation of the primary skin irritation potential are listed inTables 1, 2, 3 and 4 in the report. In this end study report, only the most important table 3 is shown.

The individual animal weights at start and end of the test are listed inTable 5 in the report.Body weights were not affected by treatment.

Under the experimental conditions employed, 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.

Direct Red 224 is, therefore, classified as a mild sensitiser in albino guinea pigs according to the Maximisation grading (Magnusson and Kligman).

According to the EEC classification criteria (Commission Directive 93/21/EEC) Direct Red 224 did not show a skin-sensitising (contact allergenic) potential in albino guinea pigs.

Table 3 Challenge reactions after epidermal application (test group)

DRAIZE Score 24 hours after removal of the dressing

Vehicle control

 

 

 

 

 

 

 

 

 

 

Male animal

166

167

168

169

170

106

107

108

109

110

Erythema score

0

0

0

0

0

0

0

0

0

0

Edema score

0

0

0

0

0

0

0

0

0

0

Female animal

176

177

178

179

180

116

117

118

119

120

Erythema score

0

0

0

0

0

0

0

0

0

0

Edema score

0

0

0

0

0

0

0

0

0

0

Test article

 

 

 

 

 

 

 

 

 

 

Male animal

166

167

168

169

170

106

107

108

109

110

Erythema score

1

0

0

0

0

0

0

0

0

0

Edema score

1

0

0

0

0

0

0

0

0

0

Female animal

176

177

178

179

180

116

117

118

119

120

Erythema score

0

0

0

0

0

0

0

1

0

1

Edema score

0

0

0

0

0

0

0

0

0

0

 

DRAIZE Score 48 hours after removal of the dressing

Vehicle control

 

 

 

 

 

 

 

 

 

 

Male animal

166

167

168

169

170

106

107

108

109

110

Erythema score

0

0

0

0

0

0

0

0

0

0

Edema score

0

0

0

0

0

0

0

0

0

0

Female animal

176

177

178

179

180

116

117

118

119

120

Erythema score

0

0

0

0

0

0

0

0

0

0

Edema score

0

0

0

0

0

0

0

0

0

0

Test article

 

 

 

 

 

 

 

 

 

 

Male animal

166

167

168

169

170

106

107

108

109

110

Erythema score

1

0

0

0

0

0

0

0

0

0

Edema score

1

0

0

0

0

0

0

0

0

0

Female animal

176

177

178

179

180

116

117

118

119

120

Erythema score

0

0

0

0

0

0

0

1

0

1

Edema score

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions employed (Guinea Pig Maximisation Test), 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
According to CLP (1272/2008) and DSD (67/548/EEC), Direct Red 224 did not show a skin-sensitising potential in albino pigs.
Executive summary:

A sensitization test was performed to determine the contact allergenic potency of Direct Red 224 in albino guinea pigs.

Total of 20 test and 10 control guinea pigs have been used.

An intradermal induction test is with 5% Direct Red 224. Epidermal applications in an induction and a challenge are with 50% Direct Red 224.

Under the experimental conditions employed (Guinea Pig Maximisation Test), 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Body weights were not affected by treatment.

According to CLP (1272/2008) and DSD (67/548/EEC), Direct Red 224 did not show a skin-sensitising potential in albino pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A sensitization test was performed to determine the contact allergenic potency of Direct Red 224 in albino guinea pigs.

Total of 20 test and 10 control guinea pigs have been used.

An intradermal induction test is with 5% Direct Red 224. Epidermal applications in an induction and a challenge are with 50% Direct Red 224.

Under the experimental conditions employed (Guinea Pig Maximisation Test), 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Body weights were not affected by treatment.

According to CLP (1272/2008) and DSD (67/548/EEC), Direct Red 224 did not show a skin-sensitising potential in albino pigs.

Justification for classification or non-classification

According to CLP (1272/2008) and DSD (67/548/EEC), Direct Red 224 did not show a skin-sensitising potential in albino pigs.