Registration Dossier
Registration Dossier
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EC number: 690-526-2 | CAS number: 38632-47-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Five male and five female RccHan:WIST (SPF) rats were treated with 1,1’-(1,6- Hexanediyldiimono)bis[1-oxo-methanesulfonic acid], sodium salt (1:2) at the limit dose of 2000 mg/kg by dermal application. The application period was 24 hours. The animals were examined for mortality, viability, clinical signs and local dermal signs. All animals were necropsied and macroscopically examined.
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt
- EC Number:
- 690-526-2
- Cas Number:
- 38632-47-2
- Molecular formula:
- C8H14S2N2O8.Na2
- IUPAC Name:
- Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt
- Details on test material:
- Purity: 91.4%
Correction Factor: 1.094
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- five male and five female animals
- Control animals:
- not required
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
Any other information on results incl. tables
No intercurrent deaths occurred during the course of the study.
No clinical signs were recorded throughout the entire observation period.
Local dermal signs such as focal crusts and desquamation were observed in four of five males and all females after test item application. Three females additionally showed slight erythema after test item application. These signs of skin irritation were reversible and receded in all animals but one male and one female until the end of the observation period.
One female slightly lost body weight in the second week after treatment. Otherwise the body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Executive summary:
Five male and five female RccHan:WIST (SPF) rats were treated with 1,1’-(1,6- Hexanediyldiimono)bis[1-oxo-methanesulfonic acid], sodium salt (1:2) at the limit dose of 2000 mg/kg by dermal application. The application period was 24 hours. The animals were examined for mortality, viability, clinical signs and local dermal signs. All animals were necropsied and macroscopically examined.
No intercurrent deaths occurred during the course of the study.
No clinical signs were recorded throughout the entire observation period.
Local dermal signs such as focal crusts and desquamation were observed in four of five males and all females after test item application. Three females additionally showed slight erythema after test item application. These signs of skin irritation were reversible and receded in all animals but one male and one female until the end of the observation period.
One female slightly lost body weight in the second week after treatment. Otherwise the body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
The median lethal dose of 1,1’-(1,6-Hexanediyldiimono)bis[1-oxo-methanesulfonic acid], sodium salt (1:2) after single dermal application to rats of both sexes, observed over a period of 14 days, is: LD50 ( rat): greater than 2000 mg/kg body weight
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