Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jan-Feb 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP Guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995
Reference Type:
review article or handbook
Title:
Acute Toxicologic Evaluation of N-Formylaminosorbit
Author:
Bomhard E, Märtins E, Stropp G
Year:
1997
Bibliographic source:
International Journal of Toxicology 16, Suppl. 2, 65, 1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
1-deoxy-1-formamido-D-glucitol
EC Number:
618-251-5
Cas Number:
89182-60-5
Molecular formula:
C7 H15 N O6
IUPAC Name:
1-deoxy-1-formamido-D-glucitol
Details on test material:
N-Formylaminosorbit, white lumpy powder, Batch: Ans. 11/91, purity 96.3%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
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 mg 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 mg and 125 mg test substance/animal)
No. of animals per dose:
control group: 10
test substance group: 20
dose range-finding groups: 1 (for intracuteneous induction), 4 (for topical indiction), 5 (for challenge)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge 50%
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%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge 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 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.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Challenge 50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Challenge 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Challenge 25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Challenge 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. 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 with the following exceptions: two animals of the treatment group showed bloody wounds and encrustations in places on the treatment areas after the 2nd induction (beginning on day 9, healing by day 14 or 15). 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 N-Formylaminosorbit 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%

Since the substance was found to be not irritating in the range-finding study, the treatment areas of the animals were pre-stimulated with sodium lauryl sulfate prior to the second induction.

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