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EC number: 200-864-0
CAS number: 75-35-4
As stated in R184.108.40.206 of the Guidance on information requirements and
chemical safety assessment chapter R.7b, the ecotoxicologic information
should cover at least three thropic levels, i.e. algae/aquatic plants,
invertebrates and fish. A first sequence of considerations is primarily
based on the availability of short-term toxicity data.
Available short-term toxicity data:
Algae (Chlamydomonas reinhardtii):
According to the key study by Brack et al. (1994) with Chlamydomonas
reinhardtii, the EC50 (72h) of 1,1 dichloroethene is 9.12 mg/l.
Invertebrates (Daphnia magna):
According to the key study according to OECD guideline 202 by Gancet
(2010) the EC50 (48h) of 1,1-dichloroethene is 37 mg/l, the NOEC (48h)
being 29.4 mg/l.
Fish (Pimephales promelas):
According to the key study by Dill et al. (1977) the LC50 (96h) of
1,1-dichloroethene is 107.9 mg/l.
Based on the data above, algae appear to be the most sensitive species,
while fish appear to be the least sensitive. Relatively to the
Chlamydomonas reinhardtii, Daphnia magna and Pimephales promelas appear
to be about 4 and 12 times less sensitive to 1,1-dichloroethene
ThePNEC aqua (freshwater)was defined according to table R.10-4 of
the Guidance on information requirements and chemical safety assessment
chapter R.10, i.e. an assessment factor of 1000 was used for the most
sensitive thropic level, i.e. algae.
ThePNEC aqua (marine water)was defined according to table R.10-5
of the Guidance on information requirements and chemical safety
assessment chapter R.10, i.e. an assessment factor of 10000 was used for
the most sensitive thropic level, i.e. algae.
As specified in R.10.3.3 of the Guidance on
information requirements and chemical safety assessment chapter R.10, thePNECwater,
intermittentis normally derived by application of an
assessment factor of 100 to the lowest L(E)C50 of at least three
short-term tests from three thropic levels.
where comp = sediment
Faircompnot relevant for sediment
Fwatersusp = 0.9 (mwater3*msusp-3) (table
0.1 (msolid3*msusp-3) (table
Focsusp* Koc = 0.1 * 52 = 2.2 (equation
0.05 (kgoc*kgsolid-1) (table
2500 (kgsolid*msolid-3) (table
PNECsed= (Ksusp-water/RHOsusp)*PNECwater*1000 (equation
Ksusp-water = 2.2
RHOsusp = 1150 (kg*m-3) (table
PNECwater (freshwater) = 0.00912 (mg/l) (IUCLID
PNECwater (saltwater) = 0.000912 (mg/l) (IUCLID
PNECsed(freshwater) = 0.0174
PNECsed (saltwater)= 0.0017
To obtain the PNECsed on a dry-weight basis, the following conversion
factor is applied
= 1150/(0.1*2500) = 4.6
=> PNECsed(freshwater) = 0.0174/CONVsusp=
0.080 mg/kg dry weight
=> PNECsed (marine water) =
0.0017/CONVsusp= 0.008 mg/kg dry weight
Microbial inhibition test data is typically
obtained from an activated sludge respiration inhibition assay.
Column 2 of Annex VIII mentions that the
activated sludge respiration inhibition assay (9.1.4) does not need to
be conducted if there are mitigating factors that microbial toxicity is
unlikely to occur”. The high vapour pressure of 1,1-dichloroethene is a
considered as such mitigating factor.
The protocol of the Activated sludge,
Respiration Inhibition Test (OECD guideline 209) specifically mentions
the importance of vapour pressure in the Qualifying statements, i. e.
“This method is most readily applied to substances which, due to their
water solubility and low volatility, are likely to remain in water.”
Because of the high volatility of 1,1-dichloroethene, concentrations
sufficient to elicit activated sludge respiration inhibition are most
unlikely to occur.
Moreover, the protocol according OECD
guideline 209 requires an active aeration (air flow of 0.5 to 1 l/min in
a total mixture volume of 0.5 l during 3h). Such circumstances further
increase the already important evaporation of 1,1-dichloroethene,
quickly lowering the 1,1-dichloroethene concentrations tested. So
similar as to the situation in a waste water treatment plant, the
activity of 1,1-dichloroethene in the Activated Sludge, Respiration
Inhibition Study can be considered primarily determined by its
volatility resulting in a limited scientific value of the study.
only relevant data (Pseudomonas putida, EC10 >2000 mg/l) originates from
a secondary data source (handbook Verschueren et al, 1996). No
verification of the original study is possible. This data source is
nevertheless mentioned in table R.7.1.-2 of chapter R 220.127.116.11 of the
Guidance on information requirements and chemical safety assessment.
2000 mg/l is used as key value in the risk assessment.
Based on the expected low potential to adsorb to soil (log
Koc=1.72) and the unlikeliness of direct and indirect exposure of the
soil compartment, terrestrial toxicity testing is not considered required
(column 2 of REACH Annex IX and X) and it is not considered relevant to
derive a PNECsoil.
Derivation of the PNEC oral was performed for sake of completeness
because 1,1 -dichloroethene shows little potential for bioaccumulation.
Equation R.10-7 was used to obtain the NOECmammal, food_chr,
NOECmammal, food_chr= NOAELmamal,
food_chr* CONVmammal[in kg.kgfood-1] where
CONVmammal= 20 (kg bw.d*kgfood–1) (Table
NOAELmamal, food_chr= 9 mg/kg= 9*10-6kg/kg, a
chronic oral rat study (Rampy et al. 1977, Quast et al.1983)
NOECmammal, food_chr= 9*10-6*20
= 1.8E-04 kg.*(kgfood–1)
The PNECoralis calculated using equation R.10-8
PNECoral= TOXoral/AForal where
TOXoral= NOECmammal, food_chr=
AForal= 30 (Table R.10-13)
/30= 6.0E-6 kg*(kgfood–1)= 6 mg*(kgfood–1)
The following ecotoxicological information is available for
Fish: No reliable chronic data available. A non-standardized acute test
in Pimephales promelas yielded a 72h-LC50 of 107.9 mg/L based on
mortality and a 72h-EC50 of 72.9 mg/L based on behaviour. Extrapolation
of these results towards the standard duration of 96h would result in an
LC50 and an EC50 below 100 mg/L. Considering this outcome, and taking
into account that the substance is not readily biodegradable leads to
the conclusion that the substance is not to be classified for acute
toxicity, and is assigned an Aquatic chronic toxicity Cat 3 for this
Daphnia: No reliable chronic data available. An acute test in Daphnia
magna yielded a 48h-EC50 of 37 mg/L based on mobility. Considering this
outcome, and taking into account that the substance is not readily
biodegradable leads to the conclusion that the substance is not to be
classified for acute toxicity, and is assigned an Aquatic chronic
toxicity Cat 3 for this trophic level.
Algae: In the available test on Chamydomonas reinhardtii, a 72h-EC50 of
9.12 mg/L (acute tox) and a 72h-EC10 of 3.94 mg/L (chronic tox) were
determined. Taking into account the availability of acute as well as
chronic data on algae leads to the conclusion that the substance is not
to be classified for acute nor chronic toxicity.
In accordance with the criteria developed in ATP 2 to EU regulation
1272/2008 (CLP), the worst-case classification obtained among the
different species is to be applied. In conclusion, 1,1-dichloroethene is
classified as Aquatic Chronic Cat. 3.
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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