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Toxicity to microorganisms

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Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an appropriate national standard method, and in compliance with GLP.
Qualifier:
according to
Guideline:
other: DIN 38412 part 27
GLP compliance:
yes
Analytical monitoring:
not specified
Test organisms (species):
Pseudomonas putida
Duration:
30 min
Dose descriptor:
EC0
Effect conc.:
> 10 000 mg/L
Conclusions:
An EC0 value of >10000 mg/l was obtained for dodecanol using an appropriate test method. The result was considered reliable.
Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP. The study is considered reliable without restriction.
Principles of method if other than guideline:
Method: other: OECD Oxygen Consumption Test
GLP compliance:
yes
Analytical monitoring:
not specified
Test organisms (species):
Pseudomonas putida
Key result
Duration:
30 min
Dose descriptor:
EC0
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Endpoint:
toxicity to microorganisms, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH
The hypothesis is that the category members have similar structures and properties (absence of effects in microorganisms up to the limit of solubility), which are consistent across the category (Scenario 6 in the RAAF). The consistency of this property across the category is discussed in the endpoint summary.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to the test material identity information within each endpoint study record. The source chemicals and the target chemical are linear aliphatic alcohols which are members of the long chain linear aliphatic alcohol Category.

The long chain linear aliphatic alcohol Category has at its centre an homologous series of increasing carbon chain length alcohols. The category members are structurally very similar. They are all primary aliphatic alcohols with no other functional groups. The category members are linear or contain a single short-chain side-branch at the 2-position in the alkyl chain, which does not significantly affect the properties (‘essentially linear’). The category members have saturated alkyl chains or contain a small proportion of naturally-occurring unsaturation(s) which does not significantly affect the properties. The branched and unsaturated structures are considered to have such similar properties that their inclusion in the category is well justified.
Impurities: Linear and/or ‘essentially linear’ long chain aliphatic alcohols of other chain lengths may be present. These are not expected to contribute significantly to the properties in respect of this endpoint due to predictable trends (see point 3).
There are no impurities present at above 1% which are not category members or which would affect the properties of the substance.

3. CATEGORY JUSTIFICATION
The category members are structurally very similar (see point 2) and are biochemically very similar. The metabolic synthesis and degradation pathways are well established. This Category is associated with a consistency and predictability in the physicochemical, environmental, and toxicological property data across its members.

The context of trends observed in this property across the range of chain lengths covered by this Category is described in the Endpoint Summary and in the Category Report attached in Section 13.

In this registration, the information requirement is interpolated based on read-across from members of the category with shorter chain length, providing evidence of consistency in properties / behaviour / effects irrespective of variation in physico-chemical properties of specific category member substances.


4. DATA MATRIX
A data matrix for the C6-24 alcohols Category is attached in Section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Duration:
30 min
Dose descriptor:
EC0
Effect conc.:
> 10 000 mg/L
Remarks on result:
other: For C12 and C18

Description of key information

Inhibition of WWTP microorganisms (tetradecan-1-ol): no significant inhibitory effects on respiration of activated sludges or specific microbial strains relevant to WWTP, at or above the limit of solubility (based on inhibition tests and lack of toxicity in ready biodegradability tests).

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
10 000 mg/L

Additional information

In accordance with Column 2 of REACH Annex VIII, the activated sludge respiration inhibition study (required in Section 9.1.4 of REACH) does not need to be conducted as the substance is readily biodegradable and the applied test concentrations are in the range that can be expected in the influent to a sewage treatment plant. Reliable studies are available, for the species Pseudomonas putida. The shorter-chain analogue dodecan-1-ol has EC0 of 10000 mg/l (Kirch 1994) and the longer-chain analogue octadecan-1-ol has EC0 of 10000 mg/l (Kirch, 1994) in the same types of study; i.e. the EC50 is greater than the limit of solubility. Tetradecanol is expected to have consistent lack of inhibition to WWTP microorganisms.

This is supported by results of non-assignable reliability studies with shorter chain-lengths within the C6 -24 Alcohols Category, indicating EC50in the hundreds of mg/l (in some cases, up to and exceeding the limit of solubility) for respiration of a mixed microbial culture. Additionally, consistent results (ECx >= 10000 mg/l) are reported in the public domain for tetradecanol and C12 -14 mixed alcohols, although original studies were not available from the data owner.

 

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

 

A number of studies of the toxicity of LCAAs to single species of micro-organisms have been identified. A range of results are shown in Table 7.21 of the Category CSR, for test species relevant to WWTP (studies on various other organisms are also available).

 

The ready biodegradation studies (Federle, 2009 and Flach, 2012, discussed in Section 5.2.1) gives evidence that rapid biodegradation by aquatic activated sludge microorganisms is seen, even in the presence of an excess of test substance (for the longer chain length category members tested). It is notable that the biodegradation in the ready test was very high compared to ThCO2, indicating that over the course of the test the exposure of organisms to test substance must have been complete.

 

At or above the limit of solubility, the data set shows that the alcohols in the chain length range C6-24 category have no significant inhibitory effects on respiration of activated sludges or specific microbial strains relevant to WWTP. There is limited evidence of inhibition of growth in some specific microbial strains but ready biodegradation evidence suggests this is not significant for mixed populations.

The reliability of some of these data individually is not high, but it presents a consistent weight of evidence.

 

In general it can be said that the micro-organisms examined in these tests were less susceptible to the LCAAs than fish, invertebrates and algae and that in general, IC50values for respiration effects are at or significantly above the limit of water solubility.

 

WWTP microorganisms have been demonstrated to be capable of synthesising significant concentrations of aliphatic alcohols (e.g. Mudge et al., 2008).

Table: Micro-organism toxicity for species of potential relevance to WWTP systems

CAS

Chemical Name

Comment

Water solubility (mg/L)

Species

Endpoint

Result (mg/L)

Effect

Reliability

Reference

111-27-3

Hexan-1-ol

 

6320

Pseudomonas putida

16-hr Toxicity Threshold (TT)

62

Cell multiplication (similar to ISO 10712)

2

Bringmann and Kuhn, 1980

111-27-3

Hexan-1-ol

 

6320

Uronema parduczi

EC0

93

Not stated

4

Verschueren, 1996

111-27-3

Hexan-1-ol

 

6320

P. putida

30 min EC10

3000

Cell multiplication (DIN 38412 Part 8)

4

Henkel unpublished

111-27-3

Hexan-1-ol

 

6320

P. putida

16-hr EC10

10,000

Respiration (DIN 38412 Part 27)

4

unreferenced; IUCLID 2000 CD-ROM

111-70-6

Heptan-1-ol

Supporting

1410

P. putida

16-hr Toxicity Threshold (TT)

67

Cell multiplication (similar to ISO 10712)

2

Bringmann and Kuhn, 1980

111-70-6

Heptan-1-ol

Supporting

1410

U. parduczi

EC0

17

Not stated

4

Verschueren, 1996

111-87-5

Octan-1-ol

 

551

P. putida

16-hr Toxicity Threshold (TT)

>50

Cell multiplication (similar to ISO 10712)

2

Bringmann and Kuhn, 1980

111-87-5

Octan-1-ol

 

551

Chilomonas paramecium

48 h EC5

>20

Cell multiplication

4

Verschueren, 1996

111-87-5

Octan-1-ol

 

551

U. parduczi

20 h TGK 5%

23

Cell multiplication

4

Bringmann and Kuhn, 1980

111-87-5

Octan-1-ol

 

551

Clostridium acetobutylicum(anaerobic)

6-h EC50

130.3

Growth

4

Izardet al., 1989

111-87-5

Octan-1-ol

 

551

 Activated sludge

3 h EC50

350

Respiration (OECD 209)

4

Tanget al., 1990

111-87-5

Octan-1-ol

 

551

 Activated sludge

EC50

325.6

Heat flux

4

Beaubienet al., 1985

111-87-5

Octan-1-ol

 

551

 Activated sludge

24h EC50

200

Respiration (other methodology)

4

Tanget al., 1990

111-87-5

Octan-1-ol

 

551

 P. putida

30 min EC10

10,000

Respiration (DIN 38412 Part 27)

4

Bringmann and Kuhn, 1980

Henkel (undated)

111-87-5

Octan-1-ol

 

551

 Mixed culture

75 min EC50

625

Respiration

4

Vaishnavet al., 1986

112-30-1

Decan-1-ol

 

39.5

P. putida

30-min. EC0

10,000

Respiration (DIN 38412 Part 27)

2

Henkel, 1999a

112-30-1

Decan-1-ol

 

39.5

Mixed microbial culture

75 min EC50

443

Respiration

4

Vaishnavet al., 1985

112-30-1

Decan-1-ol

 

39.5

 P. putida

30 min EC0

10,000

Respiration

4

Henkel, unpublished

112-53-8

Dodecan-1-ol

 

2.07

 P. putida

30-min. EC0

>10,000

Respiration (DIN 38412Part27)

1

Henkel, 1994b

80206-82-2

C12-14 Alcohols

Supporting

 

P. putida

30 min EC0

>10,000

Respiration (DIN 38412Part27)

4

Henkel unpublished

80206-82-2

C12-14 Alcohols

Supporting

 

P. putida

30 min EC0

10,000

Respiration (DIN 38412Part27)

4

Henkel unpublished

112-72-1

Tetradecan-1-ol

 

0.191

P. putida

30 min EC50

>10,000

Respiration (DIN 38412Part27)

4

Henkel unpublished

68002-94-8

C16-18 and C18 Unsaturated

Supporting

 

P. putida 

30-min. EC10

>10,000

Respiration (DIN 38412Part27)

2

Henkel, 1988a

112-92-5

Octadecan-1-ol

 

0.0011

P. putida

30-min.EC0

>10,000

Respiration (DIN 38412Part27)

1

Henkel, 1994c

References:

Bringmann, G. and Kuhn, R. 1980. Comparison of the toxicity thresholds of water pollutants to bacteria, algae, protozoa in the cell multiplication inhibition test.Water Research 14:231-241.

Verschueren, K. (ed.). 1996. Handbook of Environmental Data on Organic Chemicals. 3rd ed. New York: John Wiley & Sons, Inc.

Izardet al., 1989:  Appl. Microbiol. Biotechnol. 31, 179-183 (1989).

Tang, N.H.et al., J. Environ.Eng. (New York) 116, 1076-1084 (1990)

Beaubien, A.et al., Water Res. 19, 747-755 (1985)Beilstein On-Line database.

Vaishnav, D.D., Toxicity Assessment 1, 227-240 (1986)

Henkel KGaA.1999a. 1-Decanol: Acute toxicity bacteria. Unpublished results. Biological Research and Product Safety/Ecology. Test Substance Registration No. 7200.

Vaishnav, D.D. and Lopas, D.M. Dev. Industr. Microbiol. 26 (1985), 557-565

Henkel KGaA.1994b. Report-Nummer R 9400236. A. Kirch. Marz 1994.

Henkel KGaA. 1988a.Biological Research and Product Safety/Ecology. Test substance registration No. 6802. Bacterial toxicity.

Henkel KGaA. 1994c.1-Octadecanol: Sauerstoffzehrungshemmtest mit Bakterian. Abschlubericht. Report-Nummer R 9400049. A. Kirch. Januar 1994.

Henkel KGaA, unpublished data (1), Archive-No. 7198 (no further details available); cited in IUCLID 2000 CD-ROM (source documentation not available)

Henkel KGaA, unpublished data (2); cited in IUCLID 2000 CD-ROM (source documentation not available)

Henkel KGaA, unpublished data (3), Final Report 882633 (no further details available); cited in IUCLID 2000 CD-ROM (source documentation not available)

Henkel KGaA, unpublished data (4), Registry No. 6801 (no further details available); cited in IUCLID 2000 CD-ROM (source documentation not available)

Henkel KGaA, unpublished data (5), File 427/1 (no further details available); cited in IUCLID 2000 CD-ROM (source documentation not available)

Henkel KGaA, unpublished data (6), Test No. 9300287 31; Final Report 9500603 (no further details available); cited in IUCLID 2000 CD-ROM (source documentation not available)