Hexadecanedioic acid

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

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:

- Name of test material (as cited in study report): Sebacic Acid
- Substance type: White powder
- Physical state: Solid
- Storage condition of test material: Room temperature

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

- The test substance was added direct into the study beaker.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Supplier: Yara Tropical Fish s.r.l., Ivrea
- Body weight and length (average values) at the beginning of the study: about 0.47 g and about 3 cm
- The fish are exposed to artificial lighting with a light period of 16 hours daily
- During the acclimation the animals were fed daily with Sera sikus food. During the test the fish were fasted.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

about 228 mg of CaCO3

Test temperature:

20-22 °C

pH:

7.1-7.9

Dissolved oxygen:

7.0-8.9 mg/L

Nominal and measured concentrations:

- Nominal test concentration 100 mg/L

Details on test conditions:

- Test water was reconstituted water with Ca:Mg rate of 4:1 and a Na:K rate of 10:1
- Test vessels: glass beakers containing 5 liters
- A group of 7 animals were tested
- Treatment solution were changed every 24 hours
- Loading: maximum loading was lower than 1.0 g fish / L (about 0.46 g/L)

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- No animals in the control or treated group died.
- No animals of the control or treated group showed visible signs of abnormalities.
- The values of dissolved oxygen, pH and temperature always remained within the acceptance limits.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions the substance did not cause visible abnormalities up to a limit test nominal concentration of 100 mg/l.

Executive summary:

The toxicity to fish of the test substance was evaluated according to OECD Guideline 203. The test organisms were examined in a negative control and in a definitive test group with treatment of the test item at the nominal concentration 100 mg/l. No test organisms showed visible signs of abnormalities and there were no mortalities in either the negative control or definitive test group. In this limit test the LC50 was determined to be >100 mg/l.