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Registration Dossier
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EC number: 931-534-0 | CAS number: 68439-57-6
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: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary irritation patch test, 24h occlusive exposure on 19 human volunteers with dose finding test
- GLP compliance:
- no
Test material
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- EC Number:
- 931-534-0
- Cas Number:
- 68439-57-6
- Molecular formula:
- C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Test material form:
- other: aqueous formulation
- Details on test material:
- - Name of test material (as cited in study report): BioTerge-AS-40
- Analytical purity: No data
- Physical state: clear liquid
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 19
- Sex: 1 male, 18 female
- Age: 18 to >60 - Ethical approval:
- not specified
- Route of exposure:
- dermal
- Exposure assessment:
- estimated
- Details on exposure:
- A Q-Chamber with Webrill disc was used for occlusive exposure of 2mL of 0.3, 1 and 3.0% of the test substance. Prior application of the test patches the pH of the test material was adjusted with citric acid to achieve a range of 6-7. The test patches were placed on the back of the subjects for 24h and the reactions were examined 1/2, 24 and 48h after patch removal.
Results and discussion
- Clinical signs:
- no data
Any other information on results incl. tables
Table 1: Reactions on the test substance
|
Subjects with positive reactions/tested subjects at |
||
Concentration of test substance |
½ h |
24h |
48h |
0.3% |
3/19 |
9/19 |
2/18 |
1.0% |
6/19 |
13/19 |
4/18 |
3.0% |
11/19 |
14/19 |
5/18 |
Based on the 1/2-hour and 48-hour scorings, BioTerge AS-40 was well tolerated at concentrations of 0.3% and 1.0 % but the 24-hour scorings were in contradiction and suggested that BioTerge AS-40 showed significant skin irritation at all doses.
Applicant's summary and conclusion
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