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Diss Factsheets

Administrative data

Description of key information

In a GLP compliant, dermal irritation, study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from 24, 48 and 72 hours, was scored according to the Draize (1977) scale as follows: erythema 0.33 and edema 0.11, all observed signs of irritation completely reversed within 48 hours. Under the conditions of the test, the observed dermal reaction was not severe enough to justify a classification according to Regulation (EC) 1272/2008

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Av. of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Av. of 24, 48 and 72 hour
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Other effects:
- No abnormal physical signs were noted during the observation period.
- One animal lost body weight, all other weight changes were normal.

Table 2. Results of Observed Dermal Reactions

Observation Animal and Sex Time after patch removal Average Score of 24, 48 and 72 hrs.
60 (mins) 24 (hrs) 48 (hrs) 72 (hrs)
Erythema Score Female No. 1 2 1 0 0 0.33
Female No. 2 1 1 0 0
Male No. 3 1 1 0 0
Edema Score Female No. 1 0 0 0 0 0.11
Female No. 2 0 0 0 0
Male No. 3 1 1 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
The study concludes that the test material is a dermal irritant. However under the conditions of the test to severity of the dermal reaction observed was not enough to justify a classification according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified".
Executive summary:

In a GLP compliant, dermal irritation, study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from 24, 48 and 72 hours, was scored according to the Draize (1977) scale as follows: erythema 0.33 and edema 0.11, all observed signs of irritation completely reversed within 48 hours. Under the conditions of the test, the observed dermal reaction was not severe enough to justify a classification according to Regulation (EC) 1272/2008.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13
Reason / purpose for cross-reference:
read-across source
Controls:
other: The contralateral eye served as a control.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No reaction observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No reaction observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No reaction observed
Irritant / corrosive response data:
There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared within 72 hours.
Other effects:
- No abnormal physical signs were noted during the observation period.

Table 2. Results for Ocular Damage.

Animal No. Tissue Reading 1 hr 24 hrs 48 hrs 72 hrs Mean Score from 24, 48 and 72 hours
1 Cornea Opacity 0 0 0 0 0
  Area 0 0 0 0  
SubTotal 0 0 0 0  
Iris 0 0 0 0 0
SubTotal 0 0 0 0  
Conjunctiva Redness 2 0 0 0 0
  Chemosis 2 0 0 0 0
  Discharge 2 0 0 0  
SubTotal 12 0 0 0  
Total   12 0 0 0  
2 Cornea Opacity 0 0 0 0 0
  Area 0 0 0 0  
SubTotal   0 0 0 0  
Iris   0 0 0 0 0
SubTotal   0 0 0 0  
Conjunctiva Redness 2 1 0 0 0.33
  Chemosis 2 0 0 0 0
  Discharge 2 0 0 0  
SubTotal   12 2 0 0  
Total   12 2 0 0  
3 Cornea Opacity 0 0 0 0 0
  Area 0 0 0 0  
SubTotal   0 0 0 0  
Iris   0 0 0 0 0
SubTotal   0 0 0 0  
Conjunctiva Redness 2 1 1 0 0.66
  Chemosis 2 0 0 0 0
  Discharge 2 0 0 0  
SubTotal   12 2 2 0  
  Total   12 2 2 0  
Interpretation of results:
not irritating
Conclusions:
Under the conditions of the test, the test material was determined to be non-irritating according to Regulation (EC) 1272/2008. The material tested in this study has a TAN range of 24-40. The observed ocular effects in the three animals were not severe enough to warrant classification. Initially animals displayed mild chemosis and discharge which completely cleared by 24 hours. Two of the three animals showed mild conjunctiva redness which was completely reversible within 72 hours.
Executive summary:

In a GLP compliant study performed according to the standardised guideline EPA OPPTS 870.2440, the ocular irritation caused by exposure to the test material was assessed in three rabbits. They were exposed to 0.1 ml of the test material using their contralateral eye as a control. Initially some mild irritation (chemosis and discharge) was observed, however this did not persist past 1 hour. Conjunctiva redness was the parameter which persisted past 1 hour and was assigned an average score of 0.33 according to the Draize scale (1977), this was completely reversible within 72 hours. Under the conditions of this study the test material (which has a TAN range of 24 - 40) does not require classification as an eye irritant in line with Regulation (EC) 1272/2008.

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

Additional information

Justification for classification or non-classification

Classification criteria not met.