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EC number: 211-189-6
CAS number: 632-99-5
hydrochloride for effects in the environment:
hydrochloride(CAS no. 632-99-5) is used as a dyestuff agent and as a
biological stain. The aim was to assess whether the PBT criterion within
Annex XIII was fulfilled
hydrochloride.The PBT criterion was herein assessed based on
experimental data in conjunction with standardized environmental fate
models. Here follows a description of the PBT assessment.
The tested substance fulfils the P
criterion within Annex XIII based on the assessment that here follows:
In an experimental study from J-check
databases 2017 for the target chemical (4-(4-aminophenyl)(4-imino
-cyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride,
biodegradation experiment was conducted for evaluating the percentage
biodegradability. Biodegradation study was conducted for 28 days for
evaluating the percentage biodegradability of test substance
methyl)-2-methylaniline hydrochloride. (CAS no. 632-99-5). Concentration
of inoculum i.e, sludge used was 30 mg/l and initial test substance
conc. used in the study was 100 mg/l, respectively. The percentage
degradation of test substance was determined to 0, 13 and 2% by BOD,
TOC, and HPLC parameter in 28 days. Thus, based on percentage
degradation, (4-(4-aminophenyl)(4-imino -cyclohexa-2,5-dienylidene)
methyl)-2-methylaniline hydrochloride is considered to be not readily
biodegradable in water.
In a prediction using the Estimation
Programs Interface Suite (EPI suite, 2017) the biodegradation potential
of the test compound (4-(4-aminophenyl) (4-iminocyclohexa-2,
5-dienylidene)methyl) -2-methylaniline hydrochloride (632 -99 -5) in the
presence of mixed populations of environmental microorganisms. The
biodegradability of the substance was calculated using seven different
models such as Linear Model, Non-Linear Model, Ultimate Biodegradation
Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI
Non-Linear Model and Anaerobic Model (called as Biowin 1-7,
respectively) of the BIOWIN v4.10 software. The results indicate that
hydrochloride is expected to be not readily biodegradable.
Experimental results for the similar
substances (CAS: 2465-27-2 and 1100-88-5) also indicate that they are
not readily biodegradable.
According to the fugacity model levels
III, the most likely environmental fate for this test chemical is soil
and sediment (i.e. estimated to 54.4 and 42.5%). The half-life (120 days
in soil and 541.6 days in sediment as estimated by EPI suite) indicates
that the chemical is persistent in sediment but not persistent in soil.
If released in to the environment,
3.02% of the chemical will partition into water according to the Mackay
fugacity model level III in EPI suite version 4.1 (2017). However, the
half-life (60 days estimated by EPI suite) indicates that the exposure
risk to aquatic animals is moderate to high.
Although the half-life values indicate
that the substance is likely to be very persistent (vP), since only
estimated values are available, it is classified as persistent (P).
Hence it has been concluded
hydrochlorideis likely to be persistent in nature.
The tested substance does not
fulfil the B criterion within Annex XIII based on the assessment that
Theestimated BCF value from
authoritative databases was determined to be in the range 1 – 21.8 and
theoctanol water partition coefficient of the test chemical is 1.36
which is less than the threshold of 4.5. If this chemical is released
into the aquatic environment, there should be a low risk for the
chemical to bioaccumulate in fish and food chains.
The tested substance does not
fulfil the T criterion within Annex XIII based on the assessment that
The tested chemical is regarded to be
not classified for carcinogenicity, mutagenicity and reprotoxicity,
Further, there is no evidence of chronic toxicity, as identified by the
classifications STOT (repeated exposure), category 1(oral, dermal,
inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2
(oral, dermal, inhalation of gases/vapours, inhalation of
All of the available short-term
eco-toxicity estimations for invertebrates and algae for the substance
indicates the LC50/EC50 value to be in the range 4.3 - 1187 mg/L. These
value suggest that the substance is likely to be non-hazardous to
Aquatic organisms at environmentally relevant concentrations and can be
considered not classified as per the CLP regulation for acute toxicity.
Long-term toxicity evaluation are
hydrochloride. Long-term NOEC for fish is determined to be 3.12 mg/L for
a 60 day exposure. Since this value is much above 0.01 mg/L, the
chemical was therefore considered as non-hazardous to aquatic
environments as per the criteria set out in Annex XIII.
Based on critical, independent and
collective evaluation of information summarized herein, the tested
compound fulfils the P criterion but does not fulfil the B and T
criterion and has therefore not been classified as a PBT compound within
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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