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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions (induction phase was carried out with a non-irritating concentration instead of using a concentration causing mild irritations; no concurrent positive control was used as this was not required earlier)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): UDL 435 (P&G code)
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Physical state: white powder
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Hartley albino strain; source: Sweetwater Farms, weight at study initiation: 350 - 400 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1st: Induction 50 % occlusive epicutaneous
2nd: Induction 50 % occlusive epicutaneous
3rd: Induction 50 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1st: Induction 50 % occlusive epicutaneous
2nd: Induction 50 % occlusive epicutaneous
3rd: Induction 50 % occlusive epicutaneous
No. of animals per dose:
20
Details on study design:
30 guinea pig (Hartley albino strain; source: Sweetwater Farms, weight at study initiation: 350 - 400 g) were used in this test. 20 animals were exposed to the test substance, the remaining 10 animals served as control.
The test material was applied to four guinea pigs to determine the highest non-irritating concentration which could be applied. For this purpose UDL-435 was tested at concentrations of 50, 25 and 10% aqueous slurries. All concentrations tested revealed no skin reactions.

Induction:
The upper left quadrant of the backs of the test guinea pigs was clipped using electric clippers, on the following day the, patches were applied using a Duke Elastopatch coverlet with a 3/4 x l-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 returned to their cages.
On the following day a patch has applied, the clipped areas were depilated with ZipR (Jean Jordeau, Inc., Dist., New York). The depilatory was allowed to remain on the sites for 35-30 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
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 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

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
One animal died prior to 24 h reading, death was not attributed to sample application
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: One animal died prior to 24 h reading, death was not attributed to sample application.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
One animal died prior to 24 h reading, death was not attributed to sample application
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: One animal died prior to 24 h reading, death was not attributed to sample application.

Any other information on results incl. tables

No signs of hypersensitivity were observed. 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 test or control guinea pigs.
One animal of the control group died prior to 24-hour reading. From gross observation, death was not attributed to sample application.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information