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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
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:
other: Peer reviewed journal, read-across.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information are included in the Read-Across Justification Document.
Reason / purpose:
read-across source
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.23 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.23 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of parent animals: see below
- No. of offspring produced per day per female: see below
- Body length and weight of parent animals: not reported
- Type and number of morphological abnormalities: not reported
- Type and number of behavioural abnormalities: not reported

Summary of survival and reproduction data

Mean measured test concentration [mg/l]  SD [mg/l]  % Survival on Day 21 (SD)  Mean offspring/female (cumulative; per living female on Day 21)
0.23* 0.12   36* (14)  46* (9)
0.10 0.05  76 (31)  65 (15)
0.053 0.024  85 (24)  78 (12)
0.022 0.004  100 (0)  81 (7)
0.015 0.003  99 (2)  80 (7)
 Control  99 (2)  76 (6)

*significant effect on survival and reproduction, compared to the control.

 

Validity criteria fulfilled:
yes
Remarks:
Based on the results of studies with similiar substances (see Read-across justification document), the result of the undelrying study is considered valid and reliable, although no specific guideline and GLP compliance are mentioned.
Conclusions:
The NOEC for the toxicity of di-(n-hexyl, n-octyl, n-decyl) phthalate towards Daphnia magna is reported as 0.1 mg/l and hence above the limit of water solubilty.
Executive summary:

The underlying publication reports data for the chronic toxicity of di-(n-hexyl, n-octyl, n-decyl) phthalate towards Daphnia magna.

Daphnids were exposed to a range of concentrations ranging from 0.015 to 0.23 mg/l (mean measured) over 21 days under flow-through conditions.

No specific guideline is mentioned, but the test followed a lab internal protocol for chronic toxicity testing with invertebrates and is hence considered adequate. Survival and reproduction were monitored daily during the exposure, except for holidays, buth end points were equally sensitive.

The resulting NOEC is 0.1 mg/L.

The authors state that the exposure concentrations in this test and also in previous studies are likely to exceed the actual water solubility of the test item due to formation of micelles/microdroplets.

Staples et al. (1995) reported an aqueous solubility for di-(n-hexyl, n-octyl, n-decyl) phthalate of 0.05 mg/l.

Test organisms were found to be on the surface of the test solution in the highest concentration (=LOEC), leading to a significant effect on survival and reproduction. The reason could possibly be entrapment of daphnids by undissolved test material in form of microdroplets, as reported in former publications and reports.

Description of key information

The NOEC for the toxicity of the read-across substance 1,2-Benzenedicarboxylic acid, di.C6-C10-alkyl esters towards Daphnia magna is reported as 0.1 mg/l and hence above the limit of water solubility. Therefore it can be concluded that no toxicity occurred up to the limit of water solubility.

Key value for chemical safety assessment

Additional information

The NOEC for the toxicity of the read-across substance 1,2-Benzenedicarboxylic acid, di.C6-C10-alkyl esters towards Daphnia magna is reported as 0.1 mg/l and hence above the limit of water solubility.

For 1,2-Benzenedicarboxylic acid, diundecyl ester the NOEC (21d ) for reproduction and survival in Daphnia magna was reported as 0.059 mg /L at the highest concentration tested. Several other chronic invertebrate data is available for this substance, all showing no effects in the range of water solubility. The 21d-NOEC stated for 1,2-Benzenedicarboxylic acid, dihexyl ester is 0.084 mg/l (Rhodes et al., 1995). The same observations were made for 1,2-Benzenedicarboxylic acid, dioctyl ester in Daphnia with a reported 21d-NOEC of 0.32 mg/L.

All values are well above the level of water solubility (see Staples et al., 1997). In general, effects were only observed, if solvents were used and the limit of water solubility was exceeded.