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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not stated in paper, but submitted for publication in 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although the study is not conducted to a modern protocol and is somewhat limited, it is nevertheless fairly well documented and scientifically acceptable

Data source

Reference
Reference Type:
publication
Title:
Dermal irritancy of metal compounds. Studies with palladium, platinum, lead, and manganese compounds
Author:
Campbell KI, George EL, Hall LL and Stara JF
Year:
1975
Bibliographic source:
Archives of Environmental Health 30, 168-170

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritancy asessed using male albino rabbits using procedures and evaluation criteria adopted from those in use by the National Institute for Occupational Safety and Health, ... a modification of the official Food and Drug Administration procedure [1973]"
GLP compliance:
no
Remarks:
prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Palladium monoxide
- Other: no further details given

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Pairs of test sites, each 2 cm x 2 cm, on the closely clipped dorsolaterals aspects of each animal, one side abraded and the other side intact
Vehicle:
water
Remarks:
0.1 ml
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 hours
Observation period:
skin reactions scored immediately on removal of patch and 48 hours later
Number of animals:
Total of 6 rabbits, with up to 7 pairs of test sites each, used to test 14 test substances, some substances tested more than once
Details on study design:
Pairs of test sites, each 2 cm x 2 cm, on the closely clipped dorsolaterals aspects of each animal, one side abraded and the other side intact; Test substances in solid (powder) state were mixed with water (0.1 g quantity mixed with 0.1 ml deionised water) and spread over each site; after application of test substances [several probably tested simultaneously on each animal], test sites occluded; 24 hours later, coverings removed and test sites gently washed with soap, rinsed and dried; skin reactions scored immediately and 48 hours later; evaluation on a grading scale from 0 to 4 [similar to Draize scale]

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
single test rating or average of two or three
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Severity rating for both intact and abraded skin sites
Irritant / corrosive response data:
Average skin reaction for 24 and 72 hours after the start of treatment calculated for intact and abraded skin [no individual scores or any further information presented in paper]

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: evaluation criteria adopted from those in use by the National Institute for Occupational Safety and Health
Conclusions:
Palladium monoxide was not irritant in a limited (pre-GLP) study, involving 24-hr occluded application to the intact and abraded skin of 6 male rabbits.
Executive summary:

In a pre-GLP study, the dermal irritancy of 14 materials, including palladium monoxide, was assessed in albino rabbits. Test materials, mixed with water, were applied to intact and abraded skin of 6 male albino rabbits as 24-hour occluded patches. Coverings were then removed and sites scored immediately and 48 hours later, using a scale from 0 (non-irritant) to 4 (corrosive).

Palladium monoxide failed to give any indication of irritation (score 0) on both intact and abraded skin (mean of reactions at 24 and 72 hours).