Registration Dossier
Registration Dossier
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EC number: 943-498-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-01-12 to 2016-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP compliant study report. The Maximization test was selected since the test item is a surfactant and the Local Lymph Node Assay as preferred alternative has shown to provide false positive results for surfactants.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- PRELIMINARY irritation study:
intradermal injections:
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be injected.
Epidermal application
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be applied. Based on the results in the initially treated animals, two additional animals were epidermally treated in a similar manner with 50% at a later stage.
MAIN-Study:
Induction:
- intradermal: test item at 5% concentration
- epidermal: 50% test item concentration
Challenge:
- epidermal: 50% test item concentration - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- PRELIMINARY irritation study:
intradermal injections:
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be injected.
Epidermal application
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be applied. Based on the results in the initially treated animals, two additional animals were epidermally treated in a similar manner with 50% at a later stage.
MAIN-Study:
Induction:
- intradermal: test item at 5% concentration
- epidermal: 50% test item concentration
Challenge:
- epidermal: 50% test item concentration - No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMICALDEHYDE
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- test item at 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: test item at 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- test item at 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: test item at 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 20%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no evidence that HOSTAGEL HT 300 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0 per cent.
- Executive summary:
In order to assess the potential of the test item to induce skin sensitization a Magnusson & Kligman maximization study in guinea pigs according to OECD 406 guideline was performed.
Test item concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were epidermally challenged with a 50% test item concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals.
There was no evidence that HOSTAGEL HT 300 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0 per cent.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to assess the potential of the test item to induce skin sensitization a Magnusson & Kligman maximization study in guinea pigs according to OECD 406 guideline was performed.
Test item concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were epidermally challenged with a 50% test item concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals.
There was no evidence that HOSTAGEL HT 300 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0 per cent.
Migrated from Short description of key information:
The Maximization test was selected since the test item is a surfactant and the Local Lymph Node Assay as preferred alternative has shown to provide false positive results for surfactants.
Justification for selection of skin sensitisation endpoint:
Well documented GLP compliant study report. The Maximization test was selected since the test item is a surfactant and the Local Lymph Node Assay as preferred alternative has shown to provide false positive results for surfactants.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data no classification for skin sensitization is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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