Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-854-7 | CAS number: 127-65-1
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- Method: other: Standard CIVO procedure, TNO, Zeist, The Netherlands
- GLP compliance:
- no
Test material
- Reference substance name:
- Tosylchloramide sodium
- EC Number:
- 204-854-7
- EC Name:
- Tosylchloramide sodium
- Cas Number:
- 127-65-1
- Molecular formula:
- (C7H4SO2NCl)Na
- IUPAC Name:
- sodium chloro(4-methylbenzenesulfonyl)azanide
- Details on test material:
- Test substance: Halamid
Appearance: White crystalline powder
Purity: at least 99.8%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Details on exposure:
- Route of Administration: dermal
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- Five times a week for 6-8 hours exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25, 75 and 225 mg/kg bw/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 2
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
Results and discussion
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 25 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Remarks on result:
- other: Effects on skin
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 225 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- male
- Basis for effect level:
- clinical signs
- Remarks on result:
- other: No systemic effects observed up to 225 mg/kg bw/day.
- Dose descriptor:
- LOEL
- Effect level:
- 75 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Remarks on result:
- other: Effects on skin
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
NOAEL (NOEL), LOAEL (LOEL): = 25 mg/kg bw, 75 mg/kg bw
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX
- Time of death: no mortality or abnormalities observed.
- Number of deaths at each dose: -
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: after 21 days
- Clinical signs: at 225 mg/kg bw distinct skin lesions,
scaliness, coriaceousness, haemorrhages, fissuring and
sloughing was found. A slight scaliness and very light
coriaceousness was observed at 75 mg/kg bw. All experimental
animals showed a yellowish discolouration of the fur. No systemic
effects observed up to 225 mg/kg bw/day.
- Body weight gain: not significantly adversely affected
- Food/water consumption: not significantly adversely affected.
- Clinical chemistry: -
- Haematology: not significantly adversely affected.
- Urinalysis: not significantly adversely affected.
- Organ weights: not significantly adversely affected.
- Gross pathology: No relevant pathology was found.
- Histopathology: No relevant abnormalities found.
- Other: -
STATISTICAL RESULTS: not described
Applicant's summary and conclusion
- Conclusions:
- The No Observed Effect Level (NOEL) for systemic effects is 225 mg/kg bw/day for effects on the skin the NOEL is 25 mg/kg bw/day.
- Executive summary:
A sub acute 21 -day dermal toxicity study was performed at TNO, The Netherlands with albino rabbits. Repeated dermal application of Tosylchloramide sodium, trihydrate at a dose of 225 mg/kg bw/day resulted in distinct skin lesions consiting of scaliness, coriaceousness, haemorrhages, fissuring and sloughing. A slight scaliness and very slight coriaceousness of the exposed skin was seen in the animals of the group treated with 75 mg/kg bw/day. No distinct skin lesions were observed in the lowest dose group 25 mg/kg bw/day. All experimental animals showed a yellowish discolouration of the fur as a result of the application of Tosylchloramide sodium, trihydrate. General appearmce and behaviour, growth, food and water consumption, blood and urine composition, and organ weights were not adversely affected by the repeated dermal application Tosylchloramide sodium, trihydrate. Histologically, distinct changes of the treated skin were found in the two highest dose groups.
The No Observed Effect Level (NOEL) for systemic effects is 225 mg/kg bw/day for effects on the skin the NOEL is 25 mg/kg bw/day.
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.
