Registration Dossier
Registration Dossier
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EC number: 223-296-5 | CAS number: 3811-73-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Due to the risk of false positive results from LLNA test, the Guinea Pigs Maximisation Test was chosen.
Test material
- Reference substance name:
- Pyridine-2-thiol 1-oxide, sodium salt
- EC Number:
- 223-296-5
- EC Name:
- Pyridine-2-thiol 1-oxide, sodium salt
- Cas Number:
- 3811-73-2
- Molecular formula:
- C5H5NOS.Na
- IUPAC Name:
- sodium (1-oxo-1λ⁵-pyridin-2-yl)sulfanide
- Details on test material:
- - Analytical purity: 92.5%
- Lot/batch No.: 3811-73-2/SB-D010010
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- -Source: Harlan Winkelmann
-Age: 4-5 weeks
-Weight: 212-267g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: see below
- Concentration / amount:
- -Induction intradermal: 5% w/v in physiological saline
-Induction epicutaneous: 50% w/v in deionised water
-Challenge: 50% w/v in deionised water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: see below
- Concentration / amount:
- -Induction intradermal: 5% w/v in physiological saline
-Induction epicutaneous: 50% w/v in deionised water
-Challenge: 50% w/v in deionised water
- No. of animals per dose:
- -2x10 for test substance group
-2x5 for control group - Details on study design:
- -Induction schedule: Days 0 and 7
-Challenge schedule: Day 21
-Scoring schedule: 24h and 48h after termination of challenge exposure - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamic aldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 16.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 16.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 1.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Four animals of the test substance group died after the end of the epicutaneous induction exposure. In one animal forelimb paralysis was noted from Day 14 until the termination of the study. In step 2 signs of reduced well-being were observed in all test substance group animals some days after the end of the epicutaneous challenge exposure. The mean body weights were statistically significantly lower than those of the controls on Day 24.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Natrium Pyrion needs not to be labelled with "R43" May cause sensitisation by skin contact. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
