Registration Dossier
Registration Dossier
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EC number: 205-355-7 | CAS number: 139-13-9
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: short but sufficiently documented report
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Subacute and subchronic percutaneous studies with aqueous solution of Na3NTA (50 mg/kg/day) was applied to the clipped and abraded
backs of each of 6 animals for a period of 28 days (20 treatments). An additional group of 6 animals was treated with the same dose level applied daily for 5 days each week to intact skin for a period of 91 days (65 treatments). - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Na3NTA, no further details
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
Administration / exposure
- Duration of treatment / exposure:
- 28 or 91 days
- Frequency of treatment:
- 20 or 65 treatments
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 200 mg/kg/d
Basis:
- No. of animals per sex per dose:
- 6 per group
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Basis for effect level:
- other: NOAEL for local effects on the intact and abraded skin
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No adverse effects were observed grossly in any study. Growth, organ to body weight ratios (no data on organ weighed), and hematologic values were within the normal limits. Microscopic examination revealed that animals treated with the 10% and 11% Na3NTA solutions showed only mild skin irritation, no treatment associated change was registered in any of the 15 internal organs examined.
Although no indication on systemic effects was observed, the systemic bioavailability of Na3NTA is considered to be questionable, data reported were incompliant to standard test design and therefore a N/LOAEL for systemic toxicity can not be derived.
Applicant's summary and conclusion
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.
