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Diss Factsheets

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Internationally recognised standard; GLP guideline study
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Dicarboxylic acids are organic compounds that contain two carboxylic acid functional groups. They have the general type formula HOOC-(CH2)n-COOH. The present defined category comprises dicarboxylic acids with straight carbon chain having a “n” value from 6 to 16.
The physical and chemical properties as well as the toxicology and environmental fate and effects show that substances in this category have a similar order of toxicological and environmental fate properties, which supports the grouping of these substances as a category. (see attached justification)

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
There are number of unifying considerations justifying the similarity between these substances in some important aspects. These include:
(1) Similarity of Use: these dicarboxylic acids have several industrial uses in the production of adhesives, plasticizers, lubricants, copolymers (such as polyamides and polyesters), etc.
(2) Similarity of Functional groups: all these substances contain two common functional groups (2 carboxyl groups). The only difference between the substances of this group lies in the length of the carbon chain.
(3) Similarity of Physical / Chemical properties: the similarity of physical / chemical properties for these substances (see attached justification)
(4) Similarity of Metabolism: Dicarboxylic acids were shown to be rapidly absorbed from the gastrointestinal tract, introduced into the fatty acid catabolism and therefore extensively metabolized by the organism and excreted (Passi, S. et al, 1983).
(5) Similarity of Mammalian Toxicity: The constituents of this class have similar toxicological properties. They are not acutely toxic, irritating to skin or sensitizing. However, they all present, except for dodecanedioic acid, irritating effects on the eyes (from moderate to high effects). They do not produce systemic effects in repeated dose studies. They are neither mutagenic nor carcinogenic and do not produce developmental/reproductive toxicity. (see attached justification)
(6) Similarity of Environmental Toxicity and Fate Properties: The substances in this category have similar environmental effects properties. The environmental effects data are similar for most category members in that most members do not exhibit acute toxicity. (see attached justification)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
ISO 10253 (Water quality - Marine Algal Growth Inhibition Test with Skeletonema costatum and Phaeodactylum tricornutum)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sebacic acid
EC Number:
203-845-5
EC Name:
Sebacic acid
Cas Number:
111-20-6
Molecular formula:
C10H18O4
IUPAC Name:
sebacic acid
Details on test material:
- Substance type: White powder
- Physical state: Solid, crystalline

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
The test substance w as insoluble in water. Water accommodated fractions (WAF) were prepared individually by stirring appropriate amounts of the test substance in growth medium (according to ISO 14442:2006). The solutions w ere stirred with a spin-bar for 22 hours w ith a speed which formed a vortex one-third of the depth of the fluid content followed by standstill for about 1.5 hour.

Test organisms

Test organisms (species):
Skeletonema costatum
Details on test organisms:
- The strain of Skeletonema costatum (NIVA-BAC 1) used in this test was originally isolated from the Oslo fiord (1962).
- The culture was bought from Norsk Institut for Vannforskning (NIVA) in Oslo 25.09.2009.
- In the laboratory the algae were held at 15 +/- 2 °C under continuous light from fluorescent tubes of universal natural white type.
- The pre-culture used in this test was started 25.09.2009 and incubated on an orbital shaker.
- Sub-cultures are started twice to three times a week by transferring amounts of the growing culture to approx. 50 mL of fresh growth medium.
- The inoculum used in the present test was last fansferred on 06.11.2009.
- At the start of the test on 10.11.2009 the cell density of the inoculum w as 342000 cells/mL.
- The cell number was determined by microscope counting using a Palmer-Maloney counting slide.

Study design

Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
72 h

Test conditions

Test temperature:
19.1-20.9 °C
pH:
5.1-8.4
Salinity:
34.4 per mill
Nominal and measured concentrations:
- test substance concentrations nominal :3.0, 10.0, 31.9, 100 and 320 mg/L
Details on test conditions:
TEST SYSTEM
- Test concentrations of 50 mL were added to 100 mL flat-bottomed flasks
- 3 replicates for each concenfration and six replicates for the blank (gowth medium with no added chemicals)
- The amount of inoculum added to each test concentration was 300 µl.

TEST MEDIUM / WATER PARAMETERS
- Natural seawater from an unpolluted site at about 80 m depths in Byfjord was collected from a tap.
- The seawater was filtered through a GF/C filter and briefly heated to about 75 °C prior to use.
- The Seawater was enriched with nutrients accordimg to ISO 110253.

EFFECT PARAMETERS MEASURED
- The test was run for 72 +/- 2 hours and sub-samples of 5 ml were taken from the test flasks each day for growth measurements.
- Algal growth was measured by fluorescence on a Turner Designs, Model 10 fluorimeter.( Wavelengths: excitation 430 nm, emission > 665 nm).
- pH measurements w ere conducted at start (day 0) and at the end of the test (day 3) with a Radiometer PHM 210 instrument.
Reference substance (positive control):
yes
Remarks:
3.5-dichlorophenol

Results and discussion

Effect concentrationsopen allclose all
Duration:
72 h
Dose descriptor:
EL50
Effect conc.:
38.7 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF (Water accommodated fraction)
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
3 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF
Details on results:
A significant growth-stimulating effect was observed at the test concentration 3.0 mg/L WAF, which means that this concentration gave responses differing from the blank by showing a higher growth rate. This is why NOEC is stated as; the highest test concentration without significant growth inhibition.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the study, the 72 hours EL50 was interpolated to 38.7 mg/l WAF.
Executive summary:

The toxicity to aquatic organisms of the test substance was evaluated according to ISO 10253 (Water quality - Marine Algal Growth Inhibition Test with Skeletonema costatum and Phaeodactylum tricornutum). The test acceptance criteria given are fulfilled. The control cell density increased by a factor of more than 76 in the test period (corresponding to a growth rate of more than 0.9 d-1). The variation coefficient of the control specific growth rates did not exceed 7 %. The blank pH did not vary by more than 1.0 units during the test and the 72 hours test results with 3.5-dichlorophenol was in the range normally found.

 

Under the conditions of the study the 72 hours EL50 was interpolated to 38.7 mg/l WAF. The72 hours NOEC (No Observed Effect Concentration) the highest concentration without significant growth inhibition was 3.0m g/l WAF.