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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
OECD N°406 + EC 92/69/CEE, B6 guidelines + Maximization method of Magnusson et Kligman
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
419-690-3
EC Name:
-
Cas Number:
88020-55-7
Molecular formula:
[(C12H25)3NH]4Mo8O26
IUPAC Name:
tridodecylamine hydrate molybdenum

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Mixture of dimethylacetonide, acetone and alcohol
Concentration / amount:
Concentration of test material / induction phase (treated group) :
Intradermal : NORCAT M at 1 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol ,
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol

Concentration of test material / challenge phase (all groups) :
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol
Challengeopen allclose all
Route:
other: Topical
Vehicle:
other: Mixture of dimethylacetonide, acetone and alcohol
Concentration / amount:
Concentration of test material / induction phase (treated group) :
Intradermal : NORCAT M at 1 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol ,
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol

Concentration of test material / challenge phase (all groups) :
Topical : NORCAT M at 20 % (p/p) in a mixture of dimethylacetonide, acetone and alcohol
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20 %
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 20 %
Signs of irritation during induction: crusts, necrosis and ulcers

Comments:
No clinical signs and no deaths were noted during the study.

Since skin irritations were comparable in both groups, they were attributed to irritant properties of the test substance.


Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No cutaneous reactions attribuable to the sentization potential of the test substance NORCAT M ; it should not be classified