Registration Dossier
Registration Dossier
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EC number: 401-990-0 | CAS number: 106990-43-6 CHIMASSORB 119; LOWILITE 19
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- other: maximization test according to Magnusson and Kligman
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white strain DHP
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: First induction: sesame oil, second induction & challenge exposure: vaseline
- Concentration / amount:
- - Concentration of test material and vehicle used at induction:
First induction (intradermal injection): 1% in sesame oil and adjuvant saline mixture.
Second induction (epidermal application): 10% in vaseline.
- Concentration of test material and vehicle used for each challenge: 0.3% in vaseline.
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- other: First induction: sesame oil, second induction & challenge exposure: vaseline
- Concentration / amount:
- - Concentration of test material and vehicle used at induction:
First induction (intradermal injection): 1% in sesame oil and adjuvant saline mixture.
Second induction (epidermal application): 10% in vaseline.
- Concentration of test material and vehicle used for each challenge: 0.3% in vaseline.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
Any other information on results incl. tables
The fields "Reading", "Dose level", "No. with + reactions" and "Total no. in group" cannot be provided because the NONS file (provided by ECHA) doesn`t contain this information
Evidence of sensitisation of each challenge concentration: 60 -75% of the animals were sensitized under the experimental conditions employed.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- 60 -75% of the animals were sensitized under the experimental conditions employed. The substance is classified as a skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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