Registration Dossier
Registration Dossier
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EC number: 262-108-6 | CAS number: 60209-82-7
Direct observations: clinical cases, poisoning incidents and other
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: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- Patch test
- GLP compliance:
- no
- Remarks:
- study performed under GCP conditions
Test material
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 10
- Sex: 2 males and 8 females
- Age: 6-52 - Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- About 0.02 mL of the product (saturating a disc of filter paper placed in the patch) was applied once, on about 50 mm² of skin on the anterior side of an arm or on the scapular area of each volunteer and kept in contact with the skin for 48 h.
Negative control: same treatment, but without test item. - Examinations:
- - Skin reactions: macroscopic skin examinations were carried out immediately after patch removal (48 h post-application) and 30 min after patch removal.
-Scoring system: Internation Classification Dermatitis Reasearch Group (I.C.D.R.G.) classification:
+?: doubtful reaction. mild erythema
+: mild positive reaction (non vesiculate): erythema, infiltration sometimes several pimples
++: strong positive reaction: presence of erythema, pimples, blisters
+++: violent positive reaction with the presence of blisters
-: negative reaction
RI negative reaction
E0.5: very mild erythema
E1: mild erythema
E2: distinct erythema
E3: major erythema
Results and discussion
- Clinical signs:
- No skin reactions were observed in any subject at any reading time point.
Applicant's summary and conclusion
- Conclusions:
- Not irritating.
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