Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
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:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (maximisation).
GLP compliance:
yes
Type of study:
other: maximisation

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-140-4
EC Name:
-
Cas Number:
18934-00-4
Molecular formula:
C12H22O3
IUPAC Name:
3-ethyl-3-{[(3-ethyloxetan-3-yl)methoxy]methyl}oxetane
Test material form:
liquid

In vivo test system

Test animals

Species:
other: Guinea pig (Dunkin-Hartley)
Details on test animals and environmental conditions:
Concentration of test material and vehicle used at induction:
Intradermal Induction:
10% in Alembicol D
Topical Induction:
100%
Concentration of test material and vehicle used for each challenge:
1st challenge
a, 75% in Alembicol D
b, 37.5% in Alembicol D
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 chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
37.5%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
37.5%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 75 % Signs of irritation during induction: Intradermal Induction Slight irritation was seen in test animals at sites receiving, 10% in Alembicol D and slight irritation was observed in control animals receiving Alembicol D. Topical Application Slight erythema was observed in test animals following topical application. Slight erythema was seen in one control guinea-pig. Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of sensitisation at each challenge concentration: 0/10

Applicant's summary and conclusion

Interpretation of results:
other: not classified

Categories Display