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Diss Factsheets

Administrative data

Description of key information

Information based on three separate in-vivo tests.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1958
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in pre-GLP period but sufficient detail reported.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The irritation index is based on the Draize method in this study. Presently, this method is no longer used for determination of the degree of irritation.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
open
Preparation of test site:
abraded
Vehicle:
other: mineral oil
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 30 days
Score:
>= 0
Reversibility:
no data
Other effects:
no other effect
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irritation.
Executive summary:

The results show that all the animal treated showed a normal weight gain, sacrificed area showed normal healing, blood count showed no deviation from normal and the histological examination of the skin taken from the experimental area showed a normal picture.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP but the method used was based on scientifically accepted method.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method used was based on Draize, John H., Woodward, Geoffrey, and Calvery, Herbert 0., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Ex. Ther. 82, 377, (1944).
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino New Zeland
Details on test animals or test system and environmental conditions:
Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
24h
Observation period:
24h & 72h
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: Average of 24 and 72h
Score:
2.9
Other effects:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not a primary dermal irritant.
Executive summary:

Calculation of the primary irritation index was not correctly performed in the report as the total score should be divided by the product of the number of animals and the number of time points. In this study this means that the total score of 2.90 should be divided by 12 resulting in a primary irritation index of 0.24. According to Draize, values less than 2 should be considered as potential for slight irritation. However 100% of the text material was applied to intact and abraded skin, covered with occlusive wrapping which was only removed after 24h.

In practical, this is not possible, since treatment is immediately given when one is exposed to text material (rarely 100%). Thus, one could say that the texting material has no irritation potential.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP but the method used was based on scientifically accepted methods.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method used was based on Draize, John H., Woodward, Geoffrey, and Calvery, Herbert 0., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Ex. Ther. 82, 377, (1944).
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino New Zeland
Details on test animals or test system and environmental conditions:
Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
other: corn oil
Controls:
not required
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
24h
Observation period:
24h & 72h
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0.25
Max. score:
8
Reversibility:
fully reversible
Other effects:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not a primary dermal irritant
Executive summary:

The results show that the primary irritation index is 0.25 which means that the text material is rarely irritating to human under condition similar to rest. However 100% of the text material was applied to intact and abraded skin, covered with occlussive wrapping which was only removed after 24h.

In practical, this is not possible, since treatment is immediately given when one is exposed to text material (rarely 100%). Thus, one could say that the texting material has no irritation potential.

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The studies used for both skin and eye irritation were based on weight of evidence. Though no guideline were used in the most of the studies but the test and the scoring were based on Draize method of standard scoring which is approved according to Guidiance on the application of GLP criteria.

Justification for classification or non-classification

The test material was not classified. Thus, non- irritant to both skin and eye.