Reaction mass of 4-sulfophthalic acid and 3-sulfophthalic acid

Short-term toxicity to fish

Link to relevant study record(s)

Reference

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:

1988-01-11 - 1988-01-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Test procedure according to national standards

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read across follows Scenario 5 - Qualitatively and quantitatively similar effects are caused by a common compound, which is formed from all category members (as described in the 2017 Read-Across Assessment Framework document).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
TARGET: Reaction Mass of 4-sulphophthalic acid and 3-sulphophthalic acid (ratio 3:1)
SOURCE: Sulfophthalic acid sodium and ammonium salts

3. CATEGORY APPROACH JUSTIFICATION
Sulphophthalic acid sodium and ammonium salts are different organic salts of a common acid, sulphophthalic acid. The salts dissociate rapidly in the medium (water) to the common sulphophthalic acid anion and to their different counter ions. The counter ions ammonium and sodium do not influence the solubility and the toxicity of the category members.

4. DATA MATRIX
See Read Across document attached to CSR

Qualifier:

according to guideline

Guideline:

other: German industrial standard test guideline DIN 38 412, part L15.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The doses were chosen based on a range finding study.
- the product was added to the test water without any pretreatment

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Goldorfe
- Strain: Leuciscus idus (golden variety)
- Source: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation: 6.2 cm (range: 5.7-6.9)
- Weight at study initiation: 2.7 g (range: 2.2-3.4)
- Feeding during test: no
- Frequency: Withdrawal of food before exposure: 1 day

ACCLIMATION
- Acclimation conditions (same as test or not): oil-free aerated and charcoal filtered tap water, flow-through system
Water temperature: 20-21°C
Acclimation to test water and test temperature: 3 days

- Type and amount of food: Growing feed, F/B 50, SSNIEF Spezialdiaeten GmbH, Soest, Germany
- Feeding frequency: ad libitum.

HOUSING
- Housing water: charcoal filtered dechlorinated water in continuous flow-through
- Aeration: oilfree air
- Light regime: 16 : 8 hours light : dark
- Hardness: 2.5 mM
- Oxygen concentration: > 60 % of maximum saturation
- pH: about 8.0
- Water temperature: 20 - 22 °C
- Duration of housing: about 1 month
- Medical treatment: Once with 0.05 mg/L Malachitegreen and once with 10 mg/L tetracyclinhydrochlorid (CHECK!)
- Feeding: Growing feed, F/B 50, SSNIEF Spezialdiaeten GmbH, Soest, Germany
- Amount of feed: ad libitum
- Mortality during the last 2 weeks of housing: 0.2 %

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Hardness:

Total hardness: 2.5 mmol/L

Test temperature:

20 ±1 °C

pH:

8.0 ± 0.3

Dissolved oxygen:

7.3 - 8.4 mg/L

Nominal and measured concentrations:

Nominal concentrations: 5000 mg/L, 10000 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: aquaria open
- Material, size, fill volume: glass, 30 x 22 x 24 cm, 10 L
- Aeration: aeration with oil-free air
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 2.7 g fish /L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, part 11
- Ca/Mg ratio: 4 : 1
- Intervals of water quality measurement: 1, 24, 48, 72, and 96 hours

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light:dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, symptoms

Reference substance (positive control):

yes

Remarks:

Chloracetamid

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- LC50: ca. 31 mg/L (48 h)

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour LL50 (loading rate of test substance resulting 50% mortality) was >10,000 mg/L nominal WAF (water-accommodated fractions). No signs of toxicity were noted.

Executive summary:

There are no short-term toxicity to fish studies on the reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (target substance). However, short-term toxicity to fish data (BASF, 2012) is available for the reaction mass of 1,2-benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), sodium sulphate (source substance) and it was used for read-across purposes. In a 96-hour acute toxicity study, Golden Orfe (Leuciscus Idus L., Golden Variety) were exposed to nominal concentrations of 0 and 10,000 mg/L WAF (water-accommodated fractions) under static renewal conditions.  The 96-hour LL50 (loading rate of test substance resulting 50% mortality) was >10,000 mg/L nominal WAF. No signs of toxicity were noted.

Description of key information

There are no short-term toxicity to fish studies on the reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (target substance). However, short-term toxicity to fish data is available for the reaction mass of 1,2-benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), sodium sulphate (source substance) and it was used for read-across purposes. In a 96-hour acute toxicity study, Golden Orfe (Leuciscus Idus L., Golden Variety) were exposed to nominal concentrations of 0 and 10,000 mg/L WAF (water-accommodated fractions) under static renewal conditions.  The 96-hour LL50 (loading rate of test substance resulting 50% mortality) was >10,000 mg/L nominal WAF. No signs of toxicity were noted.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

10 000 mg/L