Registration Dossier
Registration Dossier
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EC number: 500-007-3 | CAS number: 9003-50-3
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Heptanal, oligomeric reaction products with aniline
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Heptanal, oligomeric reaction products with aniline
- Reference substance:
- Heptanal, oligomeric reaction products with aniline
- Reference substance:
- Heptanal, oligomeric reaction products with aniline
- Reference substance:
- Heptanal, oligomeric reaction products with aniline
- Reference substance:
- Heptanal, oligomeric reaction products with aniline
- PBT status:
- further information relevant for the PBT assessment is necessary
- Justification:
The substance fulfils the T and potentially fulfils the P/vP, B/vB criterion. According to the Guidance on Information Requirements and Chemical Safety Assessment Part C: PBT/vPvB assessment Version 3.0 June 2017 - Table C.4-1.
The screening criteria is as follows:
Not P and not vP: ≥70% biodegradation measured as DOC removal (OECD TGs 301A, 301E and 306) or ≥60% biodegradation measured as ThCo2 (OECD TG 301B) or ThOD (OECD TGs 301C, 301D, 301F, 306 and 310) (c)
Potentially P or vP: <70% biodegradation measured as DOC removal (OECD TGs 301A, 301E and 306) or <60% biodegradation measured as ThCo2 (OECD TG 301 B) or ThOD (OECD TGs 301C, 301D, 301F,306 and 310)
The substance has been experimentally determined to be "Not readily biodegradable", less than 25% biodegradation occurred within 14 days (20%, based on ThCO2). Therefore is considered to be potentially "Persistent/ Very Persistent"
The substance has been determined to be potentially bioacummulative/very bioaccumulative. The criteria for determining if a substance is potentially B or vB is:
Log Kow > 4.5
The substances Octanol-water partitioning coefficient was experimentally determined and gave a result of log Pow : > 7.2
The substance fulfils the Toxic criterion as it has been assigned the classification STOT RE 2, H373 based on a NOAEL of 50 mg/kg/day for females in a 28-day repeat-dose (oral) study in the rat incorporating developmental/reproductive toxicity screening study. However further data is required to clarify this position, which is not availble or a requirement at the current registration level.
Reference
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