Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.19 µg/L
Assessment factor:
2
Extrapolation method:
sensitivity distribution

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.14 µg/L
Assessment factor:
2
Extrapolation method:
sensitivity distribution

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
20 µg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.8 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.64 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.9 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.16 mg/kg food
Assessment factor:
10

Additional information

A basic assumption made in this hazard assessment and throughout this CSR, (in accordance to the same assumption made in the EU RA process) is that the ecotoxicity of CdTe is due to the Cd++ion. As a consequence, all PNEC's in this report are expressed as “cadmium”, not as CdTe as such, because ionic cadmium is considered to be the causative factor for toxicity. The only way CdTe can differ in this respect from other Cd-compounds is in its capacity to release cadmium ions into (environmental) solution. That effect is checked eventually in the transformation/dissolution tests and may result in different classification.

The in detail explained deriviation of the PNEC's of Cd for the several environmental compartments can be found back in CSR on Cd (cadmium consortium 2010). Hereunder, a brief summary of the several PNEC will be explained:

In the EU RA, it was concluded that the conditions for using a statistical extrapolation method to derive the PNEC for Cd in freshwater were met. Accordingly, this approach is also used for the present analysis. All chronic data mentioned in table below are used in a species sensitivity distribution (SSD), and the PNEC is derived based on the HC5 concentration. The HC5 calculated out of this SSD is 0.38 µg Cd/l. An AF of 2 was used. This leads to a PNEC of 0.19 µg Cd/L.

'Case-by-case”- selected NOEC data of effects of Cd in freshwater and case-by-case calculation of 'geometric mean NOEC's. Bold, underlined data are selected for the HC5calculation. (after table 3.2.9C of the EU risk assessment).

organism

medium

H

endpoint

NOEC (µg L-1)

references

Salmo gairdneri

aerated well water; T 10; O27.5; pH 8-8.6

375-390

mortality

12

Lowe-Jinde and Niimi, 1984

Salmo gairdneri

no geometric mean calculation: different test medium

synthetic water (ISO 1977) ; T 25; pH 8.3

100

median survival time

4

 

(no geomean)

Dave et al., 1981

Oncorhynchus kisutch

sand filtered Lake Superior Water; continuous flow; DO 10.3; Al 41; Ac 3; pH 7.6

45

biomass

1.3

Eaton et al., 1978

Salvelinus fontinalis

sand filtered Lake Superior Water; continuous flow; DO 10.3; Al 41; Ac 3; pH 7.6

45

biomass

1.1

 

Eaton et al., 1978

Salvelinus fontinalisgeometric mean calculation: same test medium, same endpoint (biomass)

sterilised Lake Superior water; pH 7-8; Al 38-46; Ac 1-10; DO 4-12; T 9-15

42-47

total weight of young /female of the 2nd generation

0.9 geomean =1.0

Benoit et al, 1976

Salvelinus fontinalis

reconstituted soft water: T 14-; DO 9.3-11.4 mg/L; Cd(BG) <0.2 µg/L; pH 6.3-7.6; H 20

20

survival

8

Jop et al., 1995

Salvelinus fontinalisgeometric mean calculation: similar test medium, same endpoint (survival)

river water: T 14-; DO 8.7-12.2 mg/L; Cd(BG) <4 µg/L; pH 6.6-7.4; H 16-28

16-28

survival

62 geomean =22

Jop et al., 1995

Salmo salar

municipal water charcoal filtered and UV sterilised; BC 0.13 µg Cd/L; pH 6.5-7.3; T 5-10; DO 11.1-12.5; Al 14-17

19-28

total biomass

0.47

 

Rombough and Garside, 1982

Catostomus commersoni

Esox lucius

Salvelinus namaycush

Salmo trutta (late eyed eggs)

sand filtered Lake Superior Water; continuous flow; DO 10.3; Al 41; Ac 3; pH 7.6

45

standing crop (biomass)

biomass

4.2

4.2

4.4

1.1

Eaton et al., 1978

Jordanella floridae

untreatedwater; T 25; DO 8.3; Al 42; Ac 2.4; pH 7.1-7.8

44

reproduction

4.1

Spehar, 1976

Brachydanio rerio

synthetic water (changed ISO) ; T 24; DO >80%; pH 7.2

100

reproduction

1

Bresch ., 1982

Oryzias latipes

no geometric mean calculation: different test medium

tap water; continuous flow; T 20

200

100

mortality and

abn. behaviour

6

3

 

 

Canton and Slooff, 1982

Xenopus laevis

tap water; continuous flow; T 20

170

inhibition of larvae development

9

Canton and Slooff, 1982

Pimephaless promelasgeometric mean calculation: same test medium, same endpoint (reproduction)

pond water diluted with carbon filtered demineralised tap water; DO 6.5-6.6; pH 7.6-7.7; Al 145-161; Ac 8-12; T 16-27

201-204

reproduction (pond fish)

reproduction (laboratory fry)

13

 

14geomean =13.5

Pickering and Gast, 1972

Daphnia magna

 

50 µm filtered and sterilisedwater; pH 8.1; T 20; H 224

224

intrinsic rate of natural increase

3.2

Van Leeuwen et al., 1985

Daphnia magna

no geometric mean calculation: different endpoints

NPR synthetic water; pH 8.4; T 20

200

mortality

1

 

 

Van Leeuwen et al., 1985

Daphnia magna

different medium

synthetic water; T 25; pH 8; DO 69%

11

reproduction

0.6

 

 

Kühn et al., 1989

Daphnia magna

Synthetic water; Al 65; T 25

90

reproduction

2

Winner, 1988

D. magna:

geometric mean calculation: similar medium, same endpoint)

well water: T 20±2°C; DO 4.9-7.9; Cd(BG) 0.08; pH 7.9

103

reproduction

0.16geomean =0.6

Chapman et al., 1980

 

well water: T 20±2°C; DO 4.9-7.9; Cd(BG) 0.08; pH 8.2

209

reproduction

0.21

Chapman et al., 1980t

Daphnia magna

 

unchlorinated, carbon filtered well water, aerated to saturation; Al 230; pH 8; DO >5; T 23; Cd < 0.01 µg Cd/L

240

reproductive impairment

2.5

Elnabarawy et al., 1986

Daphnia magna

no geometric mean calculation: different medium

aerated well water; DO >70%; pH 8; T 22; Al 250

300

reproduction

0.8

Knowles and McKee, 1987

Daphnia magna

culture medium; pH8.4; T 20

150

biomass production/female

2.5

Bodar et al., 1988a

Daphnia magna

no geometric mean calculation: different medium

20 µm cloth filteredwater; pH 7.7; Al 42.3; DO 9; T 18

45.3

weight/animal

 

1

Biesinger and Christensen, 1972

Daphnia pulex

 

Whatman N° 1 filteredwater; pH 7.7; Al 42.4; Cd < 1µg L-1

65

longevity

1

Bertram and Hart, 1979

Daphnia pulex

unchlorinated, carbon filtered well water, aerated to saturation; Al 230; pH 8; DO >5; T 23; Cd < 0.01 µg Cd/L

240

reproductive impairment

7.5

Elnabarawy et al., 1986

Aplexa hypnorum: immature

Lake Superiorwater; DO 7.5; T 24

 

growth

4.41

Holcombe et al., 1984

Physa integra

untreated Lake Superior water; pH 7.1-7.7; T 15; DO 10-11; Al 40-44; Ac 1.9-3

44-48

mortality

8.3

Spehar et al., 1978

Daphnia galeata mendotae

10 µm filtered Lake Michigan water; T 18.5

120

number of individuals

2

Marshall, 1978

Ceriodaphnia reticulata

unfiltered river water; static; Ac 2-4.2; Al 41-65; pH 7.2-7.8

55-79

reproduction

3.4

Spehar and Carlson, 1984

Ceriodaphnia reticulata

no geometric mean calculation:different medium

unchlorinated, carbon filtered well water, aerated to saturation; Al 230; pH 8; DO >5; T 23; Cd < 0.01 µg/L

240

reproductive impairment

0.25

Elnabarawy et al., 1986

Ceriodaphnia dubia

 no geometric mean calculation:different medium, different endpoint

Synthetic water; Al 65; T 25

90

mortality

1.5

Winner, 1988

Ceriodaphnia dubia

reconstituted soft water: T 14-; DO 9.3-11.4 mg/L; Cd(BG) <0.2 µg/L; pH 6.3-7.6; H 20

20

reproduction

10

Jop et al., 1995

Ceriodaphnia dubiageometric mean calculation:similar medium, same endpoint (reproduction)

river water: T 14-; DO 8.7-12.2 mg/L; Cd(BG) <4 µg/L; pH 6.6-7.4; H 16-28

16-28

reproduction

11geomean =10.5

Jop et al., 1995

Hyalella azteca

well water: T 23; pH 7.8

280

Survival

0.51

Ingersoll and Kemble, 2000

Chironomus tentans

well water: T 23; pH 7.8

280

weight

5.8

Ingersoll and Kemble, 2000

Selenastrum capricornutum

modified ISO 6341 medium; 0.2 µm filtered; T 20.3-25.6; pH 7.7-10.4

49

cell number

2.4

LISEC, 1998a

Coelastrum proboscideum

AM;T 31;pH 5.3;

32

biomass

6.3

Müller and Payer 1979

Asterionella formosa

AM; pH 8

121

growth rate

0.85

Conway and Williams 1979

Chlamydomonas reinhardii

AM; pH 6.7; T 20

42

steady state cell number

7.5

Lawrence et al. 1989

Scenedesmus quadricauda

AM; pH 7

 

biomass (OD)

31

Bringmann and Kühn, 1980

Lemna paucicostata

no geometric mean calculation: different medium

AM; T 25

pH>6

pH 5.1

pH 5.1

 

120

120

700

number of fronds

 

5

10

10

Nasu and Kugimoto, 1981

T = temperature (°C); H = hardness (as mg CaCO3/L); DO = dissolved oxygen (mg O2/L); Al = alkalinity (mg CaCO3/L); Ac = acidity (mg CaCO3/L); AM, artificial medium.

 

The marine cadmium database largely fulfils the species and taxonomic requirements for input chronic toxicity data as explained in the RIP R. 10 guidance (at least 10 species NOECs and 8 taxonomic groups). Indeed, 48 species mean NOECs based on 62 NOEC values, coming from 39 families and from 9 taxonomic groups covering three trophic levels were found to fulfil the relevancy and reliability requirements as explained by Klimisch et al. 1997. The marine Cd database includes 1 micro- and 1 macro-algae species, 4 annelid species, 11 crustacean species, 7 echinoderm species, 13 mollusc species, 3 nematod species, 2 cnidarian species, 1 ascidian species and 6 fish species.

Following endpoints were selected for the use in SSD for the derivation of marine PNEC for Cd.

Cadmium aquatic marine database (chronic toxicity data)

Taxonomic group

Species name

Family

Geomean NOECaddvalue

(µg Cddiss/L)

Reliability

Micro-Algae (1)

-         Chaetoceros compressum

Chaetocerotacae

18.3

2

Macro-Algae (1)

-         Ulva pertusa

Ulvaceae

63

2

Annelids

(4)

 Capitella capitata

Ctenodrilus serratus

Neanthes arenaceadontata

Ophryotrocha diadema

Capitellidae

Ctenodrilidae

Nereididae

Dorvilleidae

126.5

320.9

126.5

100

2

2

2

2

Cnidarians

(2)

 Eirene viridula

Campanularia flexuosa

Eirenidae

Campanulariidae

100

87.7

2

2

Crustaceans

(11)

Artemia franciscana

Artemia parthenogenetica

Artemia persimilis

Artemia salina

Balanus Amphitrite

Elminius modestus

Mysidopsis bahia

Paragraspus quadridentatus

Penaeus monodon

Tigriopus brevicornis

Moina monogolica

Artemiidae

Artemiidae

Artemiidae

Artemiidae

Balanidae

Archaeobalanidae

Mysidae

Grapsidae

Penaeidae

Harpacticidae

Moiniidae

39.3

106.1

99.5

56.7

5

316

2.2

105

33.3

36.7

1.8

2

2

2

2

2

2

2

2

2

2

1

Echinoderms (7)

Arbacia lixula

Asterias amurensis

Echinometra mathaei

Lytechinus pictus

Paracentrotus lividus

Sphaerechinus granularis

Strongylocentrotus droebachiensis

Arbaciidae

Asteriidae

Echinometridae

Toxopneustidae

Echinidae

Toxopneustidae

Strongylocentrotidae

357

10000

10

4.2

35.5

623

12.5

2

2

2

2

2

2

2

Molluscs

(13)

Crassostrea cucullata

Crassostrea gigas

Crassostrea margaritacea

Haliotis rubra

Ilyanassa obsolete

Isognomon californicum

Meretrix lusoria

Mya arenaria

Mytilus edulis

Mytilus galloprovincialis

Perna viridis

Ruditapes decussatus

Tresus nuttalli

Ostreidae

Ostreidae

Ostreidae

Haliotidae

Nassariidae

Isognomonidae

Veneridae

Myidae

Mytilidae

Mytilidae

Mytilidae

Veneridae

Mactridae

7.1

13

12.6

520

112.4

0.3

33.3

50

480

119.8

345.8

265

42

2

2

2

2

2

2

2

2

2

2 and 1

2 and 1

2

2

Nematods

(3)

Monhystera disjuncta

Monhysteramicrophthalma

Pellioditis marina

Monhysteridae

Monhysteridae

Rhabditidae

3333

1000

25000

2

2

2

Ascidians (1)

Ciona intestinalis

Ascidiaceae

430.5

1 and 2

Fish

(6)

Atherinops affinis

Epinephelus coioides

Lates calcarifer

Menidia menidia

Mugil cephalus

Pseudopleuronectes americanus

Atherinidae

Serranidae

Centropomidae

Atherinidae

Mugilidae

Pleuronectidae

10

33.3

794

259.8

20

283.7

1

2

2

2

2

2

TOTAL:

10 Tax. gps

 

48 species

 

39 families

 

48 species mean NOECs

 

 

The 5thpercentile value of the SSD (the HC5), set at 50% confidence value, using the lognormal distribution (ETX 2.0) function, results in a value of 2.28 µg Cd/L.This value is taken forward for the PNEC derivation. Using an AF of 2 leads to a PNEC of 1.14 µg Cd/L.

The assessment of the freshwater PNECsediment for cadmium identified only two long-term ecotoxicity studies from the scientific literature. However, both the “Added” EqP (using partitioning coefficients and a robust aquatic toxicity database from the Cd RAR) and AF (using the lowest NOEC from a field colonization study) approaches produced consistent derivations for the freshwater benthic compartment. The resulting value is considered protective for EU freshwater ecosystems:freshwater PNECadd, sedimentof 1.80 mg/kg d.w. (equivalent to 0.40 mg/kg w.w.). It is emphasized that this is an added PNEC, i.e. natural background needs to be taken into account when characterising the risk from monitored data.

The assessment of the marine PNECsediment for cadmium identified only two long-term ecotoxicity studies from the scientific literature. However, an “Added” EqP (using partitioning coefficients and a robust aquatic toxicity database) approach provided a reliable derivation for the marine benthic compartment. The resulting value is considered protective for EU marine ecosystems:marine PNECsediment, addedof 0.64 mg/kg d.w. (equivalent to 0.14 mg/kg w.w.). It is emphasised that this is an added PNEC, i.e. natural Bg needs to be taken into account when characterising the risk from monitored data.

The PNEC soil is set based on the lowest observed HC5 derived by statistical extrapolation from the microflora data, i. e.2.3 µg Cd/kg d. w. In the Cd RA, an AF 1 or 2 was considered. The current analysis rather suggests using an AF1 on the HC5 to derive the PNEC. It is noted that the PNECsoilbased on secondary poisoning is 0.9 µg Cd/g dwwhich is below the proposed value. The latter value is therefore proposed and used for PNECsoil in this assessment. This is in accordance with the approach followed in the Cd RA (ECB 2007).

The EU risk assessment discussed available data for Cd toxicity to micro-organisms. There were 2 high quality studies available, both performed according to OECD protocol (OECD 209) for testing effect on sludge respiration, showing similar NOEC values when Cd was expressed as the dissolved fraction. The LOEC values observed on the dissolved Cd fraction were high as compared to LOEC values for aquatic species. This suggested low sensitivity of bacteria to Cd was confirmed by results on bacterial cultures of Pseudomonas putida, Zoogloea ramigera and Escherichia coli, which also showed LOECs in the 1mg/l range (RA Cd/Cd0 table 3.2.32.)/ The PNEC for STP was derived in the EU risk assessment by applying an assessment factor of 10 on the lowest observed NOEC (200 µg Cd/l) which yielded a PNECSTPof 20 µg Cd/l. The same PNEC is used for the present exercise.

The EU risk assessment on cadmium identified 4 good quality feeding studies on birds and 5 studies on mammals. According to the RA, the PNEC oral secondary poisoning is derived from the lowest NOEC on Mallard ducks (1.6 mg Cd/kg diet; White et al 1978).

The PNEC oral can be calculated applying an assessment factor of 10 on this long-term feeding study, i.e. 0.16mg Cd/kg diet.

Conclusion on classification

The environmental hazard assessment and classification of CdTe under CLP is made based on CdTe-specific ecotoxicity data. Ecotoxicity tests with CdTe were performed using the standard species Daphnia magna, Pseudokirchneriella subcapitata and Danio rerio.

Acute classification of CdTe was made based on the ecotoxicity data. Ecotoxicity tests were performed using Daphnia magna, Pseudokirchneriella subcapitata and Danio rerio as test species. The lowest LC50 was observed for Daphnia magna (1.14 mg CdTe/L).

Based on this result, the conclusion is “no acute classification”.

Besides determining classification on ecotoxicity results, classification can also be determined from the T/D results. The ERV of Cd2+ is 18 µg/L. The results of the T/D tests indicates that 1mg CdTe/L brings 15 µg Cd/L into the solution. This indicates that the ERV of 18 µg Cd/L is not reached; which leads to no acute classification. This confirms the classification based on the ecotoxicity results.

For chronic classification, test results were available for Daphnia magna and Pseudokirchneriella subcapitata. The fish test was waived based on the results of the acute ecotoxicity tests, combined with the knowledge that invertebrates are the most sensitive taxonomic group for the Cd++ ion, as follows from the extensive database on chronic toxicity of soluble Cd compounds: invertebrates mean toxicity 3.04µg Cd/l (22 species NOECs, lowest value 0.21µg/l); fish mean toxicity 10.8µg Cd/l (18 species NOECs, lowest value 0.47µg/l); algae mean toxicity 9.13µg Cd/l (8 species NOECs, lowest value 0.85µg/l).

The lowest NOEC (i.e. 0.2 mg CdTe/L) was found for Daphnia magna.

For setting the chronic classification criteria, the “degradability” of the substance needs to be determined. Cadmium, like all metals, is an element, and therefore the criterion “degradability” cannot be applied as it is for organic substances. As a surrogate for assessing “degradability”, the concept of “removal from the water column” was developed to assess whether or not a given metal ion would remain present in the water column upon addition (and thus be able to excert a chronic effect) or would be rapidly removed from the water column. In this concept, “rapid removal” (defined as >70% removal within 28 days) is considered as equivalent to “rapidly degradable”. The rapid removal of Cadmium from the water column is documented under section 4.6.2, of the CSR. Consequently, the metal is considered as equivalent to being ‘rapidly degradable” in the context of classification for chronic aquatic effects. 

Considering this in combination with the ecotoxicity data given above, results in classification of CdTe for aquatic effects as "chronic 3" under CLP.