Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: ethanol
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In the sensitization test based on Magnusson and Kligman's "Guinea Pig Maximization Test", the eompound NA 872 AMINOACETATE did
not induee an allergie reaetion by skin eontaet in any of the 20 guinea pigs treated.
Thus the substanee NA 872 AMINOACETATE revealed no sensitizing potential under the stated study eonditions.
Executive summary:

A skin sensitization study with the compound NA 872 AMINOACETATE was carried out in guinea pigs from 26.02.1996 to 21.03.1996. The study was performed according to the "Guinea Pig Maximization Test" of Magnusson and Kligman, using two groups of animals: a negative control group 1 and a test group 2. The negative control group was treated during the sensitization phase in an identical manner as the test group, but only with the solvents used. The test animals of the group 2 were sensitized in two stages: a) 1 st day of study: three pairs of intradermal injections with a 1 % solution of NA 872 AMINOACETATE in absolute ethanol, a 2% solution in Freund's Complete Adjuvant (ratio FCA: absolute ethanol = 1:1) and a mixture of Freund's Complete Adjuvant with 0.9% NaCI solution in the same ratio. b) 8th to 10th day of the study: topical occlusive appl ication of a 25% suspension of NA 872 AMINOACETATE in absolute ethanol to the same area of skin. On the 22nd day of the study an attempt was made to challenge an allergie eontaet dermatitis by 24 hour topieal oeelusive applieation of a 25 % suspension of NA 872 AMINOACETATE in absolute ethanol. The skin reactions were evaluated 24 and 48 hours after removal of the occlusive system. After the challenge exposure no allergic skin reaction was registered in the guinea pigs pretreated with NA 872 AMINOACETATE. Under the stated study conditions the substance NA 872 AMINOACETATE revealed no sensitizing potential.