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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:
01/04/1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Batch number: C2413/173/3

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:
water
Concentration / amount:
Induction: 10% w/v intradermal followed 7 days later by 75% w/v epicutaneous
Challange: 10% or 25% w/v topically
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 10% w/v intradermal followed 7 days later by 75% w/v epicutaneous
Challange: 10% or 25% w/v topically
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 and 25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 and 25%. 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:
10 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: 10 and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
GR101030X produced a 0% (0/20) senistisation rate and was classified as non-sensitising to guinea pig skin.
Executive summary:

The dermal sensitisation potential of GE101030X was evaluated in the guinea pig using the Magnusson & Kligman Maximisation test. Twenty test and 10 control animals were used in the main study and based upon the results of sighting tests the following test concentrations were chosen: Intradermal induction 10% w/v in distilled water, Topical Induction: 75% w/v in distilled water, Topical challenge 10% and 25% w/v in distilled water. The test material produced a 0% (o/20) senitisation rate and was classified as a non-senitiser to gunea-pig skin.