4-chloroformylphthalic anhydride

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-03-26 to 1991-10-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1984

GLP compliance:

yes

Specific details on test material used for the study:

Trimellitic anhydride

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Leuciscus idus melanotus

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Water hardness: 231 mg CaCO3 (reconstituted water)

Test temperature:

Temperature: 22 +/- 1 degrees C.

pH:

pH: 7.0 to 7.9

Dissolved oxygen:

Dissolved oxygen concentration: 87 to 96% ASV

Nominal and measured concentrations:

Nominal concentrations: 130, 220, 350, 600 and 1000 mg TMA/L
In the definitive test the analytically determined initial concentrations of the test material were between 70% and 129% of nominal. Residual concentrations at test-end were between 36% and 92% of nominal in all three treatments that were analysed, and 91% to 92% of nominal at the maximum concentration which defined the endpoint of the study.

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 957 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: trimellitic anhydride equivalents based on measured trimellitic acid concentrations.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

957 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: trimellitic anhydride equivalents based on measured trimellitic acid concentrations

Basis for effect:

other: mortality and behavioural effects

Sublethal observations / clinical signs:

Table 1: Definitive test results: Effects of trimellitic anhydride (trimellitic acid/sodium salts) on L. idus melanotus in a 96 -hour, acute toxicity test under static conditions. Percentage mortality and sublethal effects (number showing behavioural abnormalities/number of fish per treatment).

Time (h)	Nominal trimellitic anhydride concentration (mg/L)
	0 (salinity control)*	0 (control)	130	220	350	600	1000
0	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)
3	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)
6	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)
24	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)
48	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)
72	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)
96	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)	0 (0/10)

 * The salinity control consisted of dilution water amended with NaOH solution only.

Table 2: Measured concentrations of trimellitic anhydride during a 96 hour, static acute toxicity test with L. idus melanotus

Exposure Period (h)	Nominal exposure conc. (mg TMA-equiv/L)	Measured exposure conc. (mg TMA-equiv/L)*	Percentage of nominal % #
0	130	163.7 110.2	129 86
0	350	281.2 240.3	82 70
0	1000	1058 977.1	108 100
96	130	45.8 59.0	36 46
96	350	284.5 258.9	83 75
96	1000	891.4 901.0	91 92

* Analysed as trimellitic acid, the hydrolysis product of trimellitic anhydride.

# Adjusted for 98% test substance purity.

In the report, the endpoint is given as >896 mg/L, apparently the mean measured value at the highest concentration, but based on the 96-h data only, i.e. (891.4 + 901.0)/2. This is incorrect; the mean should include the 0-h data as well, i.e. (1058 + 977.1 + 891.4 + 901.0)/4 = 957 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

The static 96-h LC0 of trimellitic anhydride (converted to trimellitic acid and its sodium salt(s) prior to exposure) to L. idus melanotus was >957 mg/L, based on the mean measured concentration at the maximum treatment applied.

Executive summary:

Golden orfe (L. idus melanotus) were exposed in a static test system over a period of 96 hours to trimellitic anhydride (TMA) after conversion with NaOH solution to the sodium salt(s) of trimellitic acid. The nominal concentrations to which the test organisms were exposed were 130, 220, 350, 600 and 1000 mg TMA-equiv/L. There were single test vessels per treatment, each containing 10 fish. Exposure concentrations were verified analytically at the start and end of the test in three of the treatments. Concentrations measured as trimellitic acid are reported as trimellitic anhydride equivalents. In the definitive test the analytically determined initial concentrations of the test material were between 70% and 129% of nominal. Residual concentrations at test-end were between 36% and 92% of nominal in all three treatments that were analysed, and 91% to 92% of nominal at the maximum concentration which defined the endpoint of the study.

The LC0 (96 h) of trimellitic anhydride to L. idus melanotus was >957 mg/L, based on the mean measured exposure concentration at the highest treatment. Trimellitic anhydride was converted to the sodium salt(s) of trimellitic acid prior to testing.

Based on the absence of treatment-related mortalities or sub-lethal effects, the NOEC was 957 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The read across justification is described in the document attached below.

Reason / purpose for cross-reference:

read-across source

Specific details on test material used for the study:

4-chloroformylphthalic anhydride

Analytical monitoring:

yes

Vehicle:

no

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 957 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: trimellitic anhydride equivalents based on measured trimellitic acid concentrations.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

957 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: trimellitic anhydride equivalents based on measured trimellitic acid concentrations

Basis for effect:

other: mortality and behavioural effects

Validity criteria fulfilled:

not applicable

Conclusions:

According to the results of the short-term toxicity test on fish performed using the source substance, the static 96h-LC0 of trimellitic anhydride (converted to trimellitic acid and its sodium salt(s) prior to exposure) to L. idus melanotus was >957 mg/L, based on the mean measured concentration at the maximum treatment applied. The same 96h-LC0 can be taken into account for the target substance.

Executive summary:

A short-term toxicity test on fish is available on the source substance trimellitic anhydride.

Golden orfe (L. idus melanotus) were exposed in a static test system over a period of 96 hours to trimellitic anhydride after conversion with NaOH solution to the sodium salt(s) of trimellitic acid. The nominal concentrations to which the test organisms were exposed were 130, 220, 350, 600 and 1000 mg trimellitic anhydride-equiv/L. There were single test vessels per treatment, each containing 10 fish. Exposure concentrations were verified analytically at the start and end of the test in three of the treatments. Concentrations measured as trimellitic acid are reported as trimellitic anhydride equivalents. In the definitive test the analytically determined initial concentrations of the test material were between 70% and 129% of nominal. Residual concentrations at test-end were between 36% and 92% of nominal in all three treatments that were analysed, and 91% to 92% of nominal at the maximum concentration which defined the endpoint of the study.

The LC0 (96 h) of trimellitic anhydride to L. idus melanotus was >957 mg/L, based on the mean measured exposure concentration at the highest treatment. Trimellitic anhydride was converted to the sodium salt(s) of trimellitic acid prior to testing.

Based on the absence of treatment-related mortalities or sub-lethal effects, the NOEC was 957 mg/L.

Based on the close structural similarity of trimellitic anhydride (source substance) and trimellitic anhydride mono-chloride (target substance), these results can be taken into account for the target substance.

Description of key information

Read-across, OECD Guideline 203, GLP, key study, validity 1:

Acute toxicity to fish: LC0 > 957 mg/L; NOEC ≥ 957 mg/L based on measured concentrations of trimellitic acid.

Additional information

To assess the short-term toxicity of the registered substance to fish, one reliable study is available on an analogue. This read-across substance is structurally related to the registered substance in that they present a close structural similarity : the study performed being on trimellitic anhydride (source substance), and the registered substance being trimellitic anhydride mono-chloride (target substance).

The available study adresses the short-term toxicity of trimellitic anhydride to freshwater fish. In this study (Knacker et al., 1993) trimellitic anhydride was first treated with aqueous NaOH solution, to convert the acid anhydride to the sodium salt(s) of trimellitic acid, and exposure in this study was consequently to sodium trimellitate (following neutralisation of excess alkali).

Based on hydrolysis rate of Trimellitic anhydride acid chloride (TMAC) and its close structural similarity, rapid hydrolysis is anticipated for trimellitic anhydride (TMA), which is also expected to undergo almost instantaneous conversion to trimellitic acid (TMLA) on contact with aqueous matrices in the environment and in vivo in exposed humans and other organisms.

No toxicity was observed under these conditions: Golden orfe (L. idus melanotus) 96-hour LC0 (static): >957 mg trimellitic acid and trimellitic sodium salts-equiv/L, 96 hour NOEC ≥ 957 mg trimellitic acid and trimellitic sodium salts-equiv/L. These endpoints are mean measured values and represent the highest concentration applied.

Trimellitic anhydride and the more environmentally relevant trimellitic acid (the hydrolysis product of the parent anhydride) exhibit very low short-term toxicity to fish.

No classification is required for the short-term toxicity to fish.