Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Desoxynojirimicin, white to beige solid powder, purity 97.7%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Win:DH
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance/animal)
Challenge: 50% and 25% (= 250 and 125 mg test substance/animal)
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance/animal)
Challenge: 50% and 25% (= 250 and 125 mg test substance/animal)
No. of animals per dose:
control group: 10
test substance group: 20
dose range-finding group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
Challenge 50% and 25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Appearance and behaviour of the test substance group were not different from the control groups. No mortalities occurred. The body weight development of the treatment group animals corresponded to that of the control group.

Applicant's summary and conclusion

Executive summary:

To determine the skin-sensitizing properties of Desoxynojirimicin the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:

intradermal induction: 5%

topical induction: 50%

challenge: 50% and 25%

Under the condition of the maximization test and with respect to the evaluation criteria Desoxynojirimicin exhibited no skin-sensitization potential.