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Toxicological information

Repeated dose toxicity: dermal

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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:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA OPP 83-2 (Carcinogenicity)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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-1lambda5-pyridin-2-yl)sulfanide
Details on test material:
Analytical purity: 41.2%
Lot/batch No.: 8508-P-166H

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.