Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
guideline study

Data source

Reference
Reference Type:
study report
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:
Study already available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
arachis oil
Concentration / amount:
25%
Day(s)/duration:
48h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, semiocclusive
Vehicle:
arachis oil
Concentration / amount:
50%
Day(s)/duration:
48h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
arachis oil
Concentration / amount:
25%
Day(s)/duration:
48
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, semiocclusive
Vehicle:
arachis oil
Concentration / amount:
50%
Day(s)/duration:
48h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Positive control substance(s):
not specified

Results and discussion

Positive control results:
see below

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
MDI-Urone is not sensitising to skin
Executive summary:

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:

Intradermal: Moderate and confluent or intense erythema and

swelling was noted at the intradermal induction sites of all

test group animals at the 24 and 48 hour observations.

Discrete or patchy erythema was noted at the intradermal

induction sites of all control group animals at the 24-hour

observation with moderate and confluent erythema at the

48-hour observation.

Topical: Discrete or patchy to moderate and confluent

erythema and incidents of very slight oedema were noted at

the induction sites of all test group animals at the 1-hour

observation. Discrete or patchy erythema and an isolated

incident of very slight oedema were noted at the induction

sites of seven test group animals at the 24-hour

observation. Discrete or patchy erythema was noted at the

treatment sites of two control group animals at the 1-hour

observation. No evidence of skin irritation was noted at the

treatment sites of control group animals at the 24-hour

observation.

Evidence of sensitisation of each challenge concentration:

0/10