Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC (Maximisation)
GLP compliance:
yes
Type of study:
other: not available
Justification for non-LLNA method:
not avaliable

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: Guinea pig (Dunkin)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
80%
No. with + reactions:
19
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40%
No. with + reactions:
19
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
80 %
No. with + reactions:
19
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
40 %
No. with + reactions:
17
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
80 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
80 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 80 %

Signs of irritation during induction:

Intradermal injection:

Necrosis was recorded in test and control animals at sites

receiving Freund's Complete Adjuvant. No irritation was

observed in controls receiving water while slight irritation

was seen in animals receiving the test substance.

Topical application:

Very slight erythema was seen in both test and control

animals.

Evidence of sensitisation of each challenge concentration:

19/20 animals at 80%

17/20 animals at 40%

Other observations:

No signs of ill health or toxicity were observed.

Bodyweight increases were recorded for all animals over the

period of the study.

Applicant's summary and conclusion

Interpretation of results:
other: irritant