Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Currenta internal SOP 00190 Version 3
Version / remarks:
This SOP is based on the Council Regulations EC No 440/2008, Guideline Part A – Methods for the Determination of the physical-chemical properties, A.6, “Water solubility” and to the OECD guideline for testing of chemicals No: 105 “Water solubility“.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Currenta internal SOP 00178 Version 3 for the determination of the pH-value
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method
Key result
Water solubility:
0.071 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 6.3 - <= 7.5
Remarks on result:
other: mean value of both columns
Conclusions:
The GLP study was performed according to OPPTS 830.7840 without deviations and therefore reliability of Klimisch 1 has been assigned. The water solubility has been determined to be 0.071 mg/L (insoluble) at 20 °C and pH 6.3 - 7.5.
Executive summary:

The water solubility of the test item pyridon was determined with the column elution method at 20 °C according to OPPTS 830.7840. The concentration of the test item in the aqueous test solutions was determined by HPLC analysis. The water solubility of the test item is stated as: 0.071 mg/L. Difference between both columns: 17 %; the validity criterion (mean of both determinations should not differ by more than 30 %) was met. The substance is insoluble in water.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion