Registration Dossier
Registration Dossier
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EC number: 290-271-3 | CAS number: 90106-48-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Secale cereale, Gramineae.
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- Adequate data from a clinical study on volunteers show the substance is not irritation for the skin. See end-point 7.10.5
- Reason / purpose for cross-reference:
- data waiving: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2005
Materials and methods
- Type of study / information:
- Acute skin tolerance on volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Skin irritation potential of the test item was studied in volunteers using 48 hour single patch test and skin reactions were evaluated.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rye, ext.
- EC Number:
- 290-271-3
- EC Name:
- Rye, ext.
- Cas Number:
- 90106-48-2
- IUPAC Name:
- Oligosaccharides and polysaccharides of glucose from Rye
- Test material form:
- liquid
- Details on test material:
- BATCH: 5.180.1
Liquid limpid
Color: yellow
Storage Condition: Room temperature
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- Volunteers of the female or male sex from 18 to 65 years of age, with a normal skin , without any dermatological lesion on the experimental area shoul be included in the study
- Exposure assessment:
- measured
- Details on exposure:
- Single application of 0.02 mL of the studied test item, on the external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).
Results and discussion
- Results:
- 12 volunteers have been included. The average irritation index is 0
Applicant's summary and conclusion
- Conclusions:
- The test item can be considered as non irritant after an application with the help of an occlusive patch for 48 h on 12 volunteers.
- Executive summary:
In a single patch test, 12 volunteers (men or women) from 28 to 62 years of age, with a normal skin, without any dermatological lesion on the experimental area, have been included in the study. Single application of 0.02 mL of the test item, on the external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers). 12 volunteers have been included and were analyzed. The average irritation index is 0.
Under the conditions employed in this study, test item was considered as non-irritant.
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