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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary study reported in summary only
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary study reported in summary form only
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study method is broadly comparable to OECD 405.
GLP compliance:
no
Remarks:
(the study pre-dates GLP)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: solitary
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
50 mg/animal
Duration of treatment / exposure:
Single exposure; no details on washing
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
no details provided
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: single exposure
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
The scores for eye irritation are not reported, however it is stated that the test material was not found to be a primary eye irritant in this study.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to the rabbit eye under the conditions of this study
Executive summary:

50 mg of the test material was instilled into one eye of two New Zealand White rabbits; ocular reactions were observed for 7 days. Scores for eye irritation are not reported, however the test material was not irritating to the rabbit eye under the conditions of this study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test method used 24-hour of semi-occlusive exposure of the interior surface of the ear of 2 rabbits.
GLP compliance:
no
Remarks:
study pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromium hydroxide sulphate
EC Number:
235-595-8
EC Name:
Chromium hydroxide sulphate
Cas Number:
12336-95-7
Molecular formula:
CrHO5S
IUPAC Name:
chromium hydroxide sulphate
Details on test material:
The test material is referred to as 'Chromsal B'

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: solitary

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
- Type of wrap if used: bandage dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water and soap/plant oil
- Time after start of exposure: 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Results are not reported in detail, however the report states that the test material is not irritating to skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Although the irritation scores are not reported, it is concluded that the test material is not a skin irritant.
Executive summary:

500 mg of the test material was applied under semi-occlusive conditions to the interior surface of the ears of two New Zealand White rabbits. Residual test material was removed after 24 hours by washing with soap and water; animals were obsereved for 7 days. Scores for irritation are not reported, however it is stated in the report that the test material was not a skin irritant under the conditions of the study. The study protocol is not standard, however it can be concluded that the substance is not a skin irritant.