Registration Dossier
Registration Dossier
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EC number: 920-338-0 | CAS number: 109236-76-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Collection of tests for various substances, predominantly in vivo.
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- The data presented in the review are reliable, because they are based on numerous qualified studies, especially for cosmetic ingredients. The structural similarity between the substance described in section 1 and the substance group in this review is obvious and significant.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Amended Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in Cosmetic Products
- Author:
- Anderson et.al.
- Year:
- 2 008
- Bibliographic source:
- International Journal of Toxicology, 27(Suppl. 4): 1-82, 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Principles of method if other than guideline:
- In the review the single methods were not specified. Some of the cited test results were maximization tests with guinea pigs, others patch tests with humans.
- GLP compliance:
- not specified
- Type of study:
- other: Several tests with different Parabens as cosmetic ingredients. Including human test data.
- Justification for non-LLNA method:
- Data from existing studies are available for structural analogues/homologues. Read Across approach.
Test material
- Reference substance name:
- Methyl 4-hydroxybenzoate
- EC Number:
- 202-785-7
- EC Name:
- Methyl 4-hydroxybenzoate
- Cas Number:
- 99-76-3
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl 4-hydroxybenzoate
- Reference substance name:
- Ethyl 4-hydroxybenzoate
- EC Number:
- 204-399-4
- EC Name:
- Ethyl 4-hydroxybenzoate
- Cas Number:
- 120-47-8
- Molecular formula:
- C9H10O3
- IUPAC Name:
- ethyl 4-hydroxybenzoate
- Reference substance name:
- Propyl 4-hydroxybenzoate
- EC Number:
- 202-307-7
- EC Name:
- Propyl 4-hydroxybenzoate
- Cas Number:
- 94-13-3
- Molecular formula:
- C10H12O3
- IUPAC Name:
- propyl 4-hydroxybenzoate
- Reference substance name:
- Butyl 4-hydroxybenzoate
- EC Number:
- 202-318-7
- EC Name:
- Butyl 4-hydroxybenzoate
- Cas Number:
- 94-26-8
- Molecular formula:
- C11H14O3
- IUPAC Name:
- butyl 4-hydroxybenzoate
Constituent 1
Constituent 2
Constituent 3
Constituent 4
In vivo test system
Test animals
- Species:
- other: numerous results from Guinea Pigs and Humans.
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- other: Several results from animal studies and human patch studies are cited in these review. Also several different test methods were applied to many structural analogues.
Any other information on results incl. tables
Several Parabenes with shorter chain length than the registered substance are widely used as preservatives in cosmetics. These Parabens were extensively tested in animal tests and, with respect to applications in cosmetic products, in patch tests to humans. The results are reported and evaluated in this review article. It is concluded, that the tested Parabens have little to no sensitizing properties.
The substance defined in section 1 has exactly the same structural components and functional groups (p-hydroxybenzoate, aliphatic chain) as the tested Parabens. Additionally, by QSAR-calculations according to relevant models (QSAR-Toolbox 3.3) no alert for sensitization can be found. Therefore, under consideration of the scope of this registration, the performance of a new study on this substance is not reasonable.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on a read across approach docosyl 4-hydroxybenzoate is not considered to be sensitizing to skin.
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