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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1985

Materials and methods

Principles of method if other than guideline:
The test material was fed in the diet to male and female rats at targeted dose levels. Parameters evaluated were general health, food consumption, body weights and gains, haematology, serum chemistry, pre-study, mid-study and final urinanalysis, absolute and relative organ weights, gross lesions and histopathologic alterations.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
sodium 3,5,6-trichloro-2-pyridinol
IUPAC Name:
sodium 3,5,6-trichloro-2-pyridinol

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
3-months
Frequency of treatment:
No data
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0 (control) mg/kgBW/day
Basis:
other: targeted dose
Remarks:
Doses / Concentrations:
10 mg/kgBW/day
Basis:
other: targeted dose
Remarks:
Doses / Concentrations:
30 mg/kgBW/day
Basis:
other: targeted dose
Remarks:
Doses / Concentrations:
100 mg/kgBW/day
Basis:
other: targeted dose
No. of animals per sex per dose:
No data
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 30 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Increased liver and kidney weights were observed in both males and females at the highest dose level.

During study, administration of the test material was also associated with observations of staining and matting of the perineal hair, often in females of the highest dose level, less often in females of the middle dose, occasionally on males of the highest dose group; and frequently in females of the low dose level group. The cause of this perineal soiling and its toxicological significance is uncertain.

Body weights and weight gains of the male middle dose level group increased along with increased food consumption, perhaps because of increased palatability.

No adverse gross or histopathological findings, urinalysis, serum chemistry, or haematology changes were found that corresponded with the increased relative liver and kidney weights, the perineal staining and matting, or the increased food consumption, body weights and body weight gains.

Applicant's summary and conclusion

Conclusions:
The NOAEL for males and females was 30 mg/kgBW/day.
Executive summary:

Increased liver and kidney weights were observed in both males and females at the highest dose level.

During study, administration of the test material was also associated with observations of staining and matting of the perineal hair, often in females of the highest dose level, less often in females of the middle dose, occasionally on males of the highest dose group; and frequently in females of the low dose level group. The cause of this perineal soiling and its toxicological significance is uncertain.

Body weights and weight gains of the male middle dose level group increased along with increased food consumption, perhaps because of increased palatability.

No adverse gross or histopathological findings, urinalysis, serum chemistry, or haematology changes were found that corresponded with the increased relative liver and kidney weights, the perineal staining and matting, or the increased food consumption, body weights and body weight gains.

The NOAEL for males and females was 30 mg/kgBW/day.