Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
other: 92/69/EEC (Maximisation)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC (Maximisation)
GLP compliance:
yes
Type of study:
other: 92/69/EEC (Maximisation)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
other: Guinea-pig (Dunkin-Hartley)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection - 0.01% w/v in distilled water
Topical Application - 3.0% w/v in distilled water
Concentration of test material and vehicle used for each challenge:
Topical application - 3.0% and 1.5% w/v in distilled water
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection - 0.01% w/v in distilled water
Topical Application - 3.0% w/v in distilled water
Concentration of test material and vehicle used for each challenge:
Topical application - 3.0% and 1.5% w/v in distilled water
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1.5 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.5 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
3%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1.5%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
3 %
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1.5%
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: 1.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
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: 3%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1.5%
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: 1.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
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: 3%. 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: 3 % Signs of irritation during induction: Slight irritation was seen in test animals following intradermal injection of the test substance.

Evidence of sensitisation of each challenge concentration: The dermal reactions seen in four of the test animals were considered to be positive sensitisation responses.

Other observations: Observations included dryness and sloughing of the epidermis, localised dermal reactions and a necrotic patch on one of the test animals.

Applicant's summary and conclusion

Interpretation of results:
other: irritant