Terpenes and Terpenoids, sinpine

Biodegradation in water: screening tests

Administrative data

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

other: based on biodegradation experimental studies of components

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Sinpine P is a multi-constituent substance. Standard biodegradation tests are not ideally suited to mixtures because they measure ultimate biodegradation as a function of either the CO2 evolved or O2 consumed and as such do not provide information on the biodegradability of individual constituents. Thus the ready biodegradability of Sinpine P has been assessed using a constituent approach.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2012

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)

Version / remarks:

D-limonene Study

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)

Version / remarks:

beta-pinene study

Principles of method if other than guideline:

The ready biodegradability of Sinpine P has been assessed using a constituent approach. Two key studies have been are used;
i) A study on D-limonene (King 1992) which represents 3 of the main constituents in Sinpine P: p-mentha-1,4(8)-diene; dipentene and p-mentha-1,4-diene
ii) A study on beta-pinene (Kreutzer 2012) which represents the 4th main constituent of Sinpine P: pine-2(3)-ene
The representative substances were chosen because they are either structurally identical to or have the same carbon skeleton as the constituents present in Sinpine P and as such are expected to have the same biodegradation properties.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Terpenes and Terpenoids, sinpine

EC Number:

272-842-9

EC Name:

Terpenes and Terpenoids, sinpine

Cas Number:

68917-63-5

IUPAC Name:

Reaction mass of 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene and 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene and 2,6,6-trimethylbicyclo[7.1.1]hept-2-ene and 1-isopropyl-4-methylcyclohexa-1,4-diene

Test material form:

not specified

Specific details on test material used for the study:

D-limonene, purity 95%
Pinene Beta, CAS 127-91-3, Batch VE00230281, purity 98.8%,

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, non-adapted

Duration of test (contact time):

28 d

Results and discussion

% Degradation

% Degradation 1

Key result

Parameter:

% degradation (CO2 evolution)

Value:

71.4

Sampling time:

28 d

Remarks on result:

other: D-limonene result represents p-mentha-1,4(8)-diene; dipentene and p-mentha-1,4-diene constituents

% Degradation 2

Key result

Parameter:

% degradation (O2 consumption)

Value:

81

Sampling time:

28 d

Remarks on result:

other: Beta-pinene result represents pin-2(3)-ene constituent

Details on results:

Ready biodegradability data for two substances has been used to assess the ready biodegradability of Sinpine P; a sealed CO2 test performed on D-limonene (King, 1992) and a Manometric Respirometry Test performed on beta-pinene (Kreutzer, 2012). The purity of the single substances tested was 95 and 98.8% respectively. The level of biodegradation achieved after 28 days was 71.4% and 81% respectively, which exceeds the pass level of 60%. The 10-day window criterion was also fulfilled in both studies. Thus D-limonene and beta-pinene can be considered as readily biodegradable.

The structures of D-limonene, beta-pinene and the four consituents of Sinpine P are provided in the "illustration section". It can be seen that D-limonene is structurally related to three of the constituents of Sinpine P (dipentene, p-mentha-1,4(8)-diene and p-mentha-1,4-diene) while beta-pinene is structurally related to the remaining constituent, pin-2(3)-ene. Given the similarity in carbon skeleton between the constituents in Sinpine P and the two substances with ready biodegradability data, it can be concluded that the 4 main constituents of Sinpine P are expected to be readily biodegradable. This is supported by data on the ECHA website for two of the constituents, p-mentha-1,4(8)diene (CAS 586-62-9) and pin-2(3)-ene (CAS 80-56-8).

Sinpine P also contains a number of identified impurities (see section 1.2 and, for chemical structures, the GCMS attached in section 1.4). The impurities are also cyclic monoterpenes and have carbon skeletons that are similar to those of the main constituents. As a consequence they are expected to be readily biodegradable. This is confirmed by data for 3 impurities, which are available in a pure form and which have been tested by the lead registrant. The study reports for these three substances are attached as background information. The results are summarsied below:

Cineole (CAS 470-82-6, also known as Eucalyptol): 90.2% after 28d (sealed CO2 test, Study No. BD/PER/09); 82% after 28 days (301F, Study No 97-E74)
Borneol (CAS 507-70-0): 99% after 28d (301F, Study No 99-E65)
Camphene (CAS 79-92-5): 78% after 28d (301F, Study No. 10-E202)

In summary, all the constituents and impurities of Sinpine P are regarded as readily biodegradable. It is thus concluded that the substance itself can be considered as readily biodegradable.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

The ready biodegradability of Sinpine P has been assessed using a constituent approach. Two key studies have been are used;
i) A study on D-limonene (King 1992) which represents 3 of the main constituents in Sinpine P: p-mentha-1,4(8)-diene; dipentene and p-mentha-1,4-diene
ii) A study on beta-pinene (Kreutzer 2012) which represents the 4th main constituent of Sinpine P: pine-2(3)-ene

D-limonene and beta-pinene achieved respectively 71.4% and 81% biodegradation after 28 days. The 10-day window criterion was also met in both studies. Thus D-limonene and beta-pinene are regarded as readily biodegradable. It is therefore considered that Sinpine P and all underlying constituents are readily biodegradable. This is further supported by available data on 3 impurities.