Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Referenceopen allclose all

Name:
2-aminopyridin-3-ol_boundary composition
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
2-aminopyridin-3-ol_boundary composition
Name:
2-aminopyridin-3-ol
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
2-aminopyridin-3-ol
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

Available test data : The substance was not readily biodegradable in a CO2 evolution test according to OECD 301 B (only 14.0% removal within the 28 day period of the study).

Screening criteria : Not readily biodegradable.

Screening assignment : P/vP screening criteria met.

 

Available QSAR data from BIOWIN v.4.10 (EPI suite TM,US EPA):

BIOWIN 2 (non-linear biodeg probability): 0.2330 (does not biodegrade fast).

BIOWIN 6 (MITI non-linear biodeg probability) : 0.1938 (not readily biodegradable).

BIOWIN 3 (survey model ultimate biodeg timeframe prediction) : 2.6631 (weeks-months).

Screening criteria:

BIOWIN 2 (non-linear biodeg probability): >=5 and BIOWIN 3 (survey model ultimate biodeg timeframe prediction) value <2.25 OR

BIOWIN 6 (MITI non-linear biodeg probability)  >=5 and BIOWIN 3 (survey model ultimate biodeg timeframe prediction)  value <2.25

Screening assignment : P/vP screening criteria not met.

 

Conclusion on P or vP properties:

The substance is potentially P/vP based on screening criteria,however,a final conclusion can not be reached based on the available information.As the substance is likely not B/vB based on screening criteria,further information for a definitive P/vP assessment was not generated.

 

Bioaccumulation

Available test data : The measured log Kow = -0.25 at 23 °C (OECD guideline 107).

Screening criteria for aquatic organisms: log Kow >4.5.

Screening assignment : B screening criteria not met.

Screening criteria for air-breathing organisms: log Kow> 2 and log Koa> 5.

Screening assignment : B screening criteria not met as log Kow <2.

Conclusion on B or vB properties

The substance is likely not B or vB based on screening criteria.

 

Toxicity

Available test data chronic toxicity:

In an oral subchronic toxicity study in rats "seizure"-like abnormalities,with clonic convulsions,vocalisation and salivation were observed in a few,short lasting cases in the high dose group.The alterations were rare,but severe and twice lethal.

Histopathologically, there were liver changes (foci of hepatocellular necrosis) in the mid-and high dosed groups at 60 and 120 mg/kg/bw.respectively,interpreted as secondary effects to unidentified primary ones and considered as test substance related effects.None of the alterations noted gives an indication for a mode of action or a specific target system or target organ.

Classification criteria: :Significant toxic effects >10 - <=100 mg/kg/bw

Based on the observed effects the substance is classified as STOT RE Category 2 ; H373 according to Regulation EC No.1272/2008.

Assignment: T criteria met

Conclusion on T properties:

The substance is classified T