Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
surface tension
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because water solubility is below 1 mg/L at 20°C
Justification for type of information:
No test was conducted as specified under COLUMN 2 "SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1" in the REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006, it states that the study does not need to be conducted if: "the water solubility is below 1 mg/l at 20 °C".

As stated in the same study number LX86WL, Envigo Research Limited WATER SOLUBILITY See IUCLID Section 4.8.

"Conclusion
The water solubility of the test item has been determined to be 3.72 x 10-4 g/L of solution at 20.0 ± 0.5 °C."
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test material

Specific details on test material used for the study:
Information as provided by the Sponsor. The Certificate of Analysis provided by the Sponsor is presented as Annex 3 (Please see Attachment Section of this Summary).

Identification: PC 1427
Appearance/Physical state: Orange/brown Liquid
Batch: 1214SA002
Purity: 100%
Expiry date: Not supplied
Storage conditions: Room temperature in the dark

Results and discussion

Applicant's summary and conclusion

Conclusions:
No test was conducted as specified under COLUMN 2 "SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1" in the REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006, it states that the study does not need to be conducted if: "the water solubility is below 1 mg/l at 20 °C".

As stated in the same study number LX86WL, Envigo Research Limited WATER SOLUBILITY See IUCLID Section 4.8.

"Conclusion
The water solubility of the test item has been determined to be 3.72 x 10-4 g/L of solution at 20.0 ± 0.5 °C."
Executive summary:

No test was conducted as specified under COLUMN 2 "SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1" in the REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006, it states that the study does not need to be conducted if: "the water solubility is below 1 mg/l at 20 °C".

As stated in the same study number LX86WL, Envigo Research Limited WATER SOLUBILITY See IUCLID Section 4.8.

"Conclusion

The water solubility of the test item has been determined to be3.72 x 10-4g/L of solution at 20.0 ± 0.5 °C."