Registration Dossier

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:
1971

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
Name:
Unnamed
Type:
Constituent
Details on test material:
Na3NTA, no further details

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