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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reporting suffers from deficiencies

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The classification of Skin irritants by human patch test
Author:
Basketer DA, Chamberlain M, Griffiths HA, Rowson M, Shittle E, York M
Year:
1997
Bibliographic source:
Food Chem Toxicol 35, 845-852
Reference Type:
publication
Title:
Determination of skin irritation potential in the human 4-h patch test
Author:
Basketer DA, York M, McFadden JP, Robinson MK
Year:
2004
Bibliographic source:
Contact Dermatitis 51, 1-4

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
patch test in humans
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data

Method

Type of population:
general
Subjects:
volunteers
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
patch test in human
Examinations:
skin irritancy
Medical treatment:
no data

Results and discussion

Clinical signs:
1/31 weekly positive reaction usually characterized by mild erythema or dryness across most of the treatment site)
compared to 17/32 in the positive control group
Results of examinations:
weekly positive reaction(usually characterized by mild erythema or dryness across most of the treatment site) was observed in 1/31 volunteers compared to 17/32 in the positive control group. Therefore it was concluded that there is no need to classify
Effectivity of medical treatment:
no data
Outcome of incidence:
1/31 (mild erythema) vs 17/32 in the positive control group

Any other information on results incl. tables

weekly positive reaction(usually characterized by mild erythema or dryness across most of the treatment site) was observed in 1/31 volunteers compared to 17/32 in the positive control group Therefore it was concluded that there is no need to classify

Applicant's summary and conclusion