Registration Dossier

Administrative data

Endpoint:
surface tension
Data waiving:
study scientifically not necessary / other information available
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:
JUSTIFICATION FOR DATA WAIVING
The water solubility is 0.034 mg/L (after 72h, at 20 °C) (exp. result, see IUCLID section 4.8, Rheinchemie, 2016).
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2015-09-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
not specified
GLP compliance:
no
Type of method:
flask method
Test material information:
Composition 1
Key result
Water solubility:
0.034 mg/L
Temp.:
20 °C
pH:
>= 4.9 - <= 6.4
Remarks on result:
other: average of solubilities determined after 24, 48, and 72h shaking
Water solubility:
0.021 mg/L
Temp.:
20 °C
pH:
5.4
Remarks on result:
other: average of solubilities determined after 24h shaking
Water solubility:
0.039 mg/L
Temp.:
20 °C
pH:
6.4
Remarks on result:
other: average of solubilities determined after 48h shaking
Water solubility:
0.041 mg/L
Temp.:
20 °C
pH:
4.9
Remarks on result:
other: average of solubilities determined after 72h shaking
Conclusions:
The water solubility of the test item (CAS 73912-21-7) was determined according to OECD 105 with accetable restrictions, using the flask method, which may be considered as a scientifically reasonable approach, and hence the result of 0.034 mg/L at 20°C can be considered to be reliable. This value is below the limit value of 0.1 mg/L, leading to the classification of the test item as insoluble.
Executive summary:

The water solubility of 2,2'-methylenebis[6-cyclohexyl-p-cresol] was determined to be 0.034 mg/L at 20°C using the shake flask method according to OECD guideline 105 (no GLP).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion