Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The procedure used was based on that of Buehler: V. Buehler "Delayed Contact Hypersensitivity in the Guinea Pig," (Arch. Dermat. 91, 171-175, 1966).
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed already in 1973 (or before) according to the Buehler test.

Test material

Constituent 1
Chemical structure
Reference substance name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
EC Number:
930-915-9
Cas Number:
1318-02-1
Molecular formula:
M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
IUPAC Name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
Test material form:
solid: particulate/powder
Remarks:
no surface treatment
Specific details on test material used for the study:
UDL-435 (A Zeolite)
white powder with no appreciable odor

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
The animals used in this study were received from Sweetwater Farms (Hartley albino strain, weight range 350-400 grams). The animals were maintained on medicated water containing 4% sulfaethoxypyridazine (6.25% S.E.Z., American Cyanamid) for three days. At the end of this period they were furnished with non-medicated water ad libitum; Purins Guinea Pig Chow was available ad libitum throughout the study. The anirnals.were acclimated to the laboratory for at least five days before they were used.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
water
Remarks:
aqueous slurry
Concentration / amount:
0.5 ml of a 50% aqueous slurry of UDL-435
Day(s)/duration:
3 times for 6 hours each (with one week pause between apllications)
Route:
epicutaneous, semiocclusive
Vehicle:
water
Remarks:
aqueous slurry
Concentration / amount:
concentrations of 50, 25 and 10% aqueous slurries of UDL-435
Day(s)/duration:
1 day
Adequacy of induction:
other: "pilot animals" group
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
water
Remarks:
aqueous slurry
Concentration / amount:
50% aqueous slurry of UDL-435
Day(s)/duration:
1 day
No. of animals per dose:
20 (+ 4 "pilot animals") dosed
10 control
Details on study design:
For the sample tested a group of 30 guinea pigs was used. The group of 30 was divided into 20 guinea pigs which served as test animals throughout the study and 10 guinea pigs wich served as controls. The latter animals were maintained without treatment until primary challenge application.
The upper left quadrant of the backs of the test guinea pigs was clipped using electric clippers, 0n the following day the, patches were applied using a Duke Elastopatch coverlet with a 3/4 x 1-inch Webril swatch moistened with 0.5 ml of a 50% aqueous slurry of UDL-435. The guinea pigs were placed in restrainers and rubber dental damming was placed over the animals' backs and secured to the restrainers with Clips. The patches were reapplied to the same site once each week for a total of three applications. After a period of six hours the patches were removed and the animals were retumed to their cages.
During the induction Phase of the study the test material was applied to four-guinea pigs to determine the highest non-frritating concentration which could be applied. For this purpose DDL-435 was tested at concentrations of 50, 25 and 10% aqueous slurries. On the day before applications were mde the backs of the guinea pigs were clipped with electric clippers. This provided space to test four concentrations on each guinea pig.
On the following day a patch has applied to each animal using the materials and methods described previously. On the next day the clipped areas were depilated with Zip (Jean Jordeau, Inc., Dist., New York). The depilatory was allowed to remain on the sites for 15-30 minutes and then washed off with warm (ca. 37°C) tap water.
The patch sites were scored for irritation three to five hours later.
Challenge controls:
After a two-week rest period after the induction Phase, a fresh application site for primary challenge was prepared by clipping the lower left quadrant of the backs of the test and control guinea pigs. On the following day a challenge patch was applied to the site using a 50% aqueous slurry of UDL-435 and the techniques described previously.
On the next day the sites were depilated and scored within three to five hours (24-hour reading). The sites were scored again for a 48-hour reading without additional depilation.
Positive control substance(s):
no

Results and discussion

Positive control results:
no positve control group

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: "pilot animals"
Dose level:
10%, 25%, 50%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not specified
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
from gross observation the death of one animal was not attributed to sample application
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9

Any other information on results incl. tables

"Pilot animals": Irritation scores in albino guinea pigs following a single application at varying concentrations of UDL-435.


 


Treatment and negative control groups: Scores recorded at primary challenge for test albino guinea pigs which received three weekly induction applications and one primary challenge application and for control animals which received a single primary challenge application of a 50% aqueous slurry of UDL-435.


 


No reaction was noted in any of the four pilot pigs tested at concentrations of 50, 25 and 10% aqueous slurries. UDL-435 as a 50% aqueous slurry produced no reaction in any of the twenty test or nine (one animal died prior to reading) control guinea pigs.

Applicant's summary and conclusion

Conclusions:
When tested according to the method of Buehler, UDL-435 produced no reaction resembling hypersensitivity in any test or control animal.
Executive summary:

To evaluate the potential of UDL-435 to induce hypersensitivity in guinea pigs a procedure based on the Buehler test was applied.

No reaction was noted in any of the four pilot pigs tested at concentrations of 50, 25 and 10% aqueous slurries, also UDL-435 as a 50% aqueous slurry produced no reaction in any of the twenty test or nine control guinea pigs.