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Diss Factsheets

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:
December 26-29,1990
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:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSA 16 CFR 1500.41
Deviations:
no
Principles of method if other than guideline:
The test item was applied on intact and abraded skin of New Zealand Albino rabbits and occluded for 24 h. Sites were evaluated 24 and 72 h after initial exposure according to the method of Draize.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Didysprosium trioxide
EC Number:
215-164-0
EC Name:
Didysprosium trioxide
Cas Number:
1308-87-8
Molecular formula:
Dy2O3
IUPAC Name:
dysprosium(3+); oxygen(2-)
Test material form:
solid: particulate/powder
Details on test material:
Name: dysprosium oxide
Purity: 96%
Lot number: #DY-spcl
Appearance: off-white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, New Brunswick, NJ
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: Individually, in suspended stainless steel cages with mesh floors.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): Tap water supplied by automatic water system
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72-75 F
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one intact and one abraded site per rabbit
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
The sites were evaluated 24 and 72 hours after initial exposure.
Number of animals:
6: 3 male, 3 female
Details on study design:
TEST SITE
- Area of exposure: ca. 2.5 cm2
- % coverage: no data
- Type of wrap if used: adhesive-backed gauze patch, wrapped with elastic cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
- 24 and 72 h after initial exposure

SCORING SYSTEM:
- Method of calculation: According to Draize (1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
measured at 24 h and 72 h
Irritant / corrosive response data:
There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not found to be irritating to skin under the conditions of the study. The test item is not classified for skin irritation under the CLP Regulation.