Registration Dossier
Registration Dossier
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EC number: 223-296-5 | CAS number: 3811-73-2
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- repeated dose toxicity: dermal
- Remarks:
- combined repeated dose and carcinogenicity
- 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:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPP 83-2 (Carcinogenicity)
- GLP compliance:
- yes
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: 41.2%
Lot/batch No.: 8508-P-166H
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River UK
Age at study initiation: 6 weeks
Weight at study initiation: male 19-31g female 18-27g
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Details on exposure:
- -10% body area
-1ml/kg bw - Duration of treatment / exposure:
- -80 weeks
-Test substance was not removed - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 15, 40 mg/ml
Basis:
- No. of animals per sex per dose:
- 50
Examinations
- Observations and examinations performed and frequency:
- -Body weight weekly for 1st 16 weeks then every 4 weeks
-Food consumption weekly for 1st 16 weeks then every 4 weeks
-Clinical signs daily
-Palpable masses and skin tumours weekly starting week 27 - Sacrifice and pathology:
- -Haematology
-Pathology
-Organ weights liver kidneyys, testes, brain
-Histopathology Brain, spinal cord, pituitary, thyroid, parathyroid, thymus, oesophagus, salivary glands, stomach, small and large intestines, rectum ,liver, pancreas, kidneys, application site, adrenals, spleen, heart, trachea, lungs, aorta, aortic arch, gonads, uterus, female mammary gland, prostate, seminal vesicles, epididymides, urinary bladder, gall bladder, lymph nodes (mesenteric, submandibular), sciatic nerve, bone marrow, skin, eyes, skeleteal muscle, bone (sternum and femus), caecum, urethra - Statistics:
- Body weight, haematological, and organ weight data were evaluated by analysis of variance and, if a between-group difference significant at the 5% level occured, by pairwise t-tests between the control and treatment groups.
Results and discussion
Results of examinations
- Details on results:
- An NOEL of 5.0 mg/kg bw/day was established in the study for any signs of toxicity with 15.0 mg/kg/day resulting in a tendency for dermal irritiaton.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- Toxicity
- Effect level:
- 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no substance-related findings were observed
- Dose descriptor:
- NOEL
- Remarks:
- Dermal Irritation
- Effect level:
- 15 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no substance-related findings were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality data
| 0 mg/kg | 5 mg/kg | 15 mg/kg | 40 mg/kg | |
| Killed in extremis during study | 3M 6F | 3M 9F | 4M 6F | 5M 7F |
| Killed in extremis during necropsy period | 0M 2F | 0M 2F | 0M 0F | 0M 1F |
| Found dead | 6M 6F | 3M 3F | 1M 2F | 3M 5F |
| Total mortality | 9M 14F | 6M 14F | 5M 8F | 8M 13F |
| Mortality as % of group size | 18M 28F | 12M 28F | 10M 16F | 16M 26F |
Applicant's summary and conclusion
- Conclusions:
- An NOEL of 5.0 mg/kg bw/day was established in the study for any signs of toxicity with 15.0 mg/kg/day resulting in a tendency for dermal irritiaton. 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.
