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Diss Factsheets

Administrative data

Description of key information

A sample of the test item was tested for skin irritation potential according to the procedure prescribed by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41. 0.5 g of the sample was mixed with 0.5 ml of distilled water before application to the skin of tested rabbits.


For the eye irritation testing, the procedure employed was that prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42. 79 mg of sample was instilled into one eye of each six rabbits, while the untreated eye was used as concurrent control. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: limited justification
Qualifier:
according to guideline
Guideline:
other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no
Specific details on test material used for the study:
Sample code n°: 507-43
Species:
rabbit
Strain:
other: Albino rabbit
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: Distilled water
Amount / concentration applied:
0.5 g of test item mixed with 0.5 ml of distilled water
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Sample 507-43 is not considered to be an irritant to rabbit skin.
Executive summary:

Sample 507-43 was tested according to the procedure prescribed by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41, a transcript of which is attached as an Appendix to the full study report.


0.5 g of the sample 507-43 was mixed with 0.5 ml of distilled water before application to the skin of tested rabbits.


None of the animals showed any observable response to treatment throughout the 72 hours observation period. 


Therefore, sample 507-43 is not considered to be an irritant to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no
Specific details on test material used for the study:
Sample code n°: 507-43
Species:
rabbit
Strain:
other: Albino rabbit
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
79 mg
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.72
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The numerical scores awarded to the ocular reactions elicited by test sample 507-43 are given in section "Any other information on results incl. tables".
None of the animals gave a positive reaction. Mild conjunctival reactions (redness) were observed in all six animals.

The numerical scores awarded to the ocular reactions elicited by Sample 507-43 are presented in Table 1 below:  


 























































































































































































































































Table 1

Animal No.



Region of eye



Day



Positive (+) or Negative (-) Result



1



2



3



4



7



14



1



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



0



1



1



1



1



0



Conjunctivae chemosis



0



0



0



0



0



0



2



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



1



1



1



1



0



Conjunctivae chemosis



1



0



0



0



0



0



3



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



1



1



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



4



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



1



1



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



5



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



0



0



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



6



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



0



0



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



 

Interpretation of results:
GHS criteria not met
Conclusions:
Sample 507-43 gave a negative result for eye irritation, according to the definition given in the Code of Federal Regulations of the U.S.A.
Executive summary:

The procedure employed was that prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42, a transcript of which is attached as an Appendix to the full study report.


For the test, 79 mg of sample 507-43 was instilled into one eye of each six animals, while the untreated eye was used as concurrent control. 


The numerical scores awarded to the ocular reactions elicited by 507-43 are given in Table 1: none of the animals gave a positive reaction and only mild conjunctival reactions were observed in all six animals.


Sample 507-43 gave a negative test for eye irritation, according to the definition given in the Code of Federal Regulations of the U.S.A.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Skin irritation:
None of the animals showed any observable response to treatment throughout the 72 hours observation period. Therefore, the test item is not considered to be an irritant to rabbit skin.


 


Eye irritation: 
None of the animals gave a positive reaction and only mild conjunctival reactions were observed in all six animals. The test item gave a negative test for eye irritation, according to the definition given in the Code of Federal Regulations of the U.S.A.