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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The results of several repeated dose toxicity studies using the oral route of administration were cited in peer reviewed and authorative secondary sources with no or very limited information on methodology provided. The lowest NOAEL was cited for a one year chronic oral toxicity study in dogs as stated in the US-EPA RED (2005) document. More specifically, the NOAEL was determined to be 3 mg/kg bw/day. Due to the limited information content of the peer reviewed and authorative secondary sources the available data is not sufficient to derive a classification.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Authorative secondary source with limited information provided. Original study report was not available.
Principles of method if other than guideline:
Secondary literature source no data about the method was available.
GLP compliance:
not specified
Species:
dog
Sex:
not specified
Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
52 -week
Remarks:
Doses / Concentrations:

Basis:

Positive control:
not applicable
Details on results:
Considering liver enzymes, liver weights and liver lesions at a LOAEL of 15 mg/kg/day, the NOAEL is 3 mg/kg/day.
Dose descriptor:
NOAEL
Effect level:
3 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LOAEL
Effect level:
15 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
3 mg/kg bw/day
Study duration:
chronic
Species:
dog
Quality of whole database:
Authorative secondary source with dose decriptor provided only. Original study report was not available.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity oral:

The results of several repeated dose toxicity studies using the oral route of administration were cited in peer reviewed and authorative secondary sources with no or very limited information on methodology provided.

Yano et al. (2008) reported that the repeated dose toxicity of the test item was evaluated in a 2 -week feeding study with mice using the following dose levels: 0, 5, 25, 75, 150, 200, 400 or 600 mg/kg bw/day. The NOEL was determined to be 150 mg/kg bw/day.

Moreover, Yano et al. (2008) reported that the repeated dose toxicity of the test item was evaluated in a 13 -week feeding study with mice using the following dose levels: 0, 15, 45, 90 and 180 mg/kg bw/day. The NOEL was determined to be 45 mg/kg bw/day.

The US-EPA RED (2005) document reports the results of a subchronic (3-month) oral toxicity study of test item in the mouse via dietary administration. The NOAEL and the LOAEL for males were determined to be 200 and 300 mg/kg bw/day, respectively. The NOAEL for females was determined to be 400 mg/kg bw/day.

The US-EPA RED (2005) document reports the results of a two year chronic toxicity and oncogenicity study in Fischer 344 rats. The NOAEL and the LOAEL for toxicity were determined to be 5 and 20 mg/kg bw/day, respectively.

The US-EPA RED (2005) document reports the results of chronic (one-year) dietary toxicity study in dogs. The NOAEL and the LOAEL for males were determined to be 3 and 15 mg/kg bw/day, respectively.

Due to the limited information content of the peer reviewed and authorative secondary sources the available data is not sufficient to derive a classification.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Chronic oral toxicity study conducted with dogs and with lowest NOAEL observed. Due to the limited information content of the peer reviewed and authorative secondary sources the available data is not sufficient to fully address this endpoint.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

According to the harmonised Annex I classification the substance is not considered to be classified for repeated dose toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.  

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

According to the harmonised Annex VI classification the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.