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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 March 2002 to 08 September 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study was conducted using equivalent methodology to the relevant international guideline (OECD 111). The study was not conducted in accordance with GLP, but was well reported and is considered suitable as a key study for this endpoint.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
no
Remarks:
Internal data conducted by the registrant (non-GLP) were already available for this substance. The quality of the data (considering non-GLP status), including the detail of reporting, was considered suitable to fulfil the endpoint.
Analytical monitoring:
yes
Details on sampling:
Small aliquots of the test solution are extracted with an organic solvent (typically cyclohexane or ethyl acetate) containing a hydrocarbon standard (typically C12, C17 or C20) on a regular basis throughout the test (at time = 0, 0.21, 1, 2, 4, 8, 15, 22 and 28 days).
Buffers:
pH 2 ( 0.1) buffer : Reference Handbook of Chemistry and Physics buffer type A
pH 5 ( 0.1) buffer : Reference Handbook of Chemistry and Physics buffer type C
pH 7 ( 0.1) buffer : Reference Handbook of Chemistry and Physics buffer type D
pH 8.5 ( 0.1) buffer : Reference Handbook of Chemistry and Physics buffer type F
pH 12 ( 0.1) buffer : Reference Handbook of Chemistry and Physics buffer type I
Details on test conditions:
The test media are standard aqueous buffers at pH 2, pH 5, pH 7, pH 8.5 and pH 12 containing 1% of non ionic surfactant. The tests are done in accelerated conditions at 40°C for one month.
Duration:
28 d
pH:
2
Temp.:
40 °C
Remarks:
Screening test
Duration:
28 d
pH:
5
Temp.:
40 °C
Remarks:
Screening test
Duration:
28 d
pH:
7
Temp.:
40 °C
Remarks:
Screening test
Duration:
28 d
pH:
8.5
Temp.:
40 °C
Remarks:
Screening test
Duration:
28 d
pH:
12
Temp.:
40 °C
Remarks:
Screening test
Number of replicates:
A single replicate was used for each pH level assessed for hydrolytic stability.
Positive controls:
no
Negative controls:
no
Statistical methods:
No statistical analysis was required.
Transformation products:
not measured
Key result
pH:
5
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
8.5
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
Constituent 1:
The parent compound is stable (less than 10% disappearance) up to 5 days in the range of pH from 5 to 12 at 40oC. At pH 2, 20% disappeared after 5 days, and around 50% after 28 days. At other pH from 5 to 12 after 28 d, 20 to 25% of the parent compound was remaining. It can be concluded that under the conditions of the present test, COMPONENT number 1, (4R)-4-isopropenyl-1-methylcyclohexene is hydrolytically stable at pH 5 to 12 (as defined in the OECD TG 111 for hydrolysis as a function of pH).

Constituent 2:
The parent compound is stable (around 10% disappearance) up to 28 days in the range of pH from 5 to 8.5 at 40oC. At pH 2, only 30% of (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene remained after 28d. It can be concluded that under the conditions of the present test, (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene is hydrolytically stable (as defined in the OECD TG 111 for hydrolysis as a function of pH).
Results with reference substance:
Not conducted
Validity criteria fulfilled:
yes
Conclusions:
Based on a preliminary test, conducted using an equivalent method to OECD 111, the substance is considered hydrolytically stabel (DT50 (25 °C) = >1 year).
Executive summary:

In a study conducted in accordance with OECD 111 (EU Method C.7), the hydrolytic stability of each of the constituent components of the substance was assessed at pH 2, 5, 7, 8.5 and 12 at 40 °C.

For constituent 1, the parent compound is stable (less than 10% disappearance) up to 5 days in the range of pH from 5 to 12 at 40oC.  At pH 2, 20% disappeared after 5 days, and around 50% after 28 days. At other pH from 5 to 12 after 28 d, 20 to 25% of the parent compound was remaining. It can be concluded that under the conditions of the present test, COMPONENT number 1, (4R)-4-isopropenyl-1-methylcyclohexene is hydrolytically stable at pH 5 to 12 (as defined in the OECD TG 111 for hydrolysis as a function of pH).

For constituent 2, the parent compound is stable (around 10% disappearance) up to 28 days in the range of pH from 5 to 8.5 at 40oC.  At pH 2, only 30% of (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene remained after 28d. It can be concluded that under the conditions of the present test, (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene is hydrolytically stable (as defined in the OECD TG 111 for hydrolysis as a function of pH).

Under the conditions of the test, the substance is considered hydrolytically stabel (DT50 (25 °C) = >1 year).

Description of key information

Hydrolytic half life (25 °C) = > 1 year; OECD 111; Anon. (2016)

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information

In a study conducted in accordance with OECD 111 (EU Method C.7), the hydrolytic stability of each of the constituent components of the substance was assessed at pH 2, 5, 7, 8.5 and 12 at 40 °C.

For constituent 1, the parent compound is stable (less than 10% disappearance) up to 5 days in the range of pH from 5 to 12 at 40oC.  At pH 2, 20% disappeared after 5 days, and around 50% after 28 days. At other pH from 5 to 12 after 28 d, 20 to 25% of the parent compound was remaining. It can be concluded that under the conditions of the present test, COMPONENT number 1, (4R)-4-isopropenyl-1-methylcyclohexene is hydrolytically stable at pH 5 to 12 (as defined in the OECD TG 111 for hydrolysis as a function of pH).

For constituent 2, the parent compound is stable (around 10% disappearance) up to 28 days in the range of pH from 5 to 8.5 at 40oC.  At pH 2, only 30% of (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene remained after 28d. It can be concluded that under the conditions of the present test, (4R)-4-(2-methoxypropan-2-yl)-1-methylcyclohexene is hydrolytically stable (as defined in the OECD TG 111 for hydrolysis as a function of pH).

Under the conditions of the test, the substance is considered hydrolytically stabel (DT50 (25 °C) = >1 year).