Phthalic acid

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

no

Specific details on test material used for the study:

phthalic anhydride, purity >= 98 % (FA Merck)

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

solvent: DMSO < 100 µl/l
test concentration: 5 - 7, a solvent and blank control; range between the concentrations
was 3.2

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

60 d

Test temperature:

10 +/- 1 °C

Duration:

60 d

Dose descriptor:

LOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: total embryotoxicity

Duration:

60 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: any effects: mortality, lengh, weight, embryotoxicity

Details on results:

Geometric series of 7 test concentrations using a factor of 3.2 was used. With a factor of 3.2 the next lowest concentration is 10 mg/l which
corresponds to the no effect concentration (NOEC) of 10 mg/l.

EC50 (Total Embryotoxicity): 44.1 mg/l
LC50                       : 44.2 mg/l
LOEC (mortality):              32 mg/l
LOEC (total embryotoxicity):   32 mg/l
LOEC (length):                 32 mg/l
LOEC (weight):                 32 mg/l

LOEC: The lowest concentration which differed significantly from the  control. 

Geometric series of 7 test concentrations using a factor of 3.2 was used.
  With a factor of 3.2 the next lowest concentration is 10 mg/l which  
corresponds to the no effect concentration (NOEC) of 10 mg/l.

RS-Freetext:
The LC50 and 95 % confidence limits were determined according to 
Kooyman  (1981)*. Concentrations affecting survival with more than 50 % were  excluded from the statistical analyses. The Bartlett test was used to  test the data for homogeneity of variances. Differences were considered  significant at alpha < 0.01.


* Kooyman SALM (1981). Parametric analyses of mortality rates in  
bioassays. Water Res. 15, 107-119.

Executive summary:

A chronic toxicity test of phthalic anhydride to fish was performed with Oncorhynchus mykiss (Salmo gairdneri) according to the OECD Guideline Draft "Early Life Stage". After 60 days an effective LOEC of 32 mg/l was determined. Geometric series of 7 test concentrations using a factor of 3.2 were used. With a factor of 3.2 the next lowest concentration is 10 mg/l which corresponds to the no effect concentration (NOEC). Not only mortality but also other endpoints like total embryotoxicity were tested (Van Leeuwen, 1990).

Reference 2

Endpoint:

fish early-life stage toxicity

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Phthalic anhydride, the cyclic anhydride of phthalic acid, is used for the read across.
For further information see attached document:
Justification for a read-across between phthalic acid and phthalic anhydride

Reason / purpose for cross-reference:

read-across source

Duration:

60 d

Dose descriptor:

LOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: total embryotoxicity

Duration:

60 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: any effects: mortality, length, weight

Description of key information

Concerning long-term toxicity of phthalic acid to fish, an early life stage toxicity test using phthalic anhydride as test substance was taken into account. The test was performed according to the Draft Guideline OECD 210, and was carried out in buffered medium using Salmo gairdneri (new name: Oncorhynchus mykiss) as test species. A NOEC of 10 mg/l was derived from the test results (Van Leeuwen, 1990).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

10 mg/L

Additional information

Due to fast hydrolysis the value of phthalic anhydride was considered here to
assess long-term toxicity to fish of phthalic acid. A chronic toxicity test
of phtalic anhydride to fish was performed with
Oncorhynchus mykiss (Salmo gairdneri) according to the
OECD Guideline Draft "Early Life Stage" 210 in buffered medium under semi static
conditions. Fertilised eggs and the following early-life stages of fish were
exposed to geometric series of 7 test concentrations for 60 days.
An effective LOEC of 32mg/l was determined. With a factor of 3.2 the next lowest
concentration is 10 mg/l which corresponds to the no effect concentration (NOEC.
Due to fast hydrolysis the value of phthalic anhydride was considered here to
assess long-term toxicity to fish of phthalic acid. A chronic toxicity test of
phtalic anhydride to fish was performed with Oncorhynchus mykiss (Salmo gairdneri)
according to the OECD Guideline Draft "Early Life Stage" 210 in buffered medium
under semi static conditions. Fertilised eggs and the following early-life stages
of fish were exposed to geometric series of 7 test concentrations for 60 days.
An effective LOEC of 32mg/l was determined. With a factor of 3.2 the next lowest
concentration is 10 mg/l which corresponds to the no effect concentration (NOEC).
Not only mortality but also other endpoints like total embryotoxicity were tested.