p-mentha-1,4-diene

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

p-mentha-1,4-diene

EC Number:

202-794-6

EC Name:

p-mentha-1,4-diene

Cas Number:

99-85-4

Molecular formula:

C10H16

IUPAC Name:

p-mentha-1,4-diene

Specific details on test material used for the study:

Test substance: Gamma Terpinene
Chemical name (IUPAC): 1-isopropyl-4-methylcyclohexa-1,4-diene
CAS RN: 99-85-4
Molecular mass (a.i.): 136.23 g•mol-1
Received on: 01/Mar/2017
Bioagri Laboratórios Ltda. code: AGR-0158/17
Declared concentration (a.i.): 98.00% (m/m)
Analyzed concentration (a.i.) (Bioagri Laboratórios Ltda.): 98.22% (m/m)
Certificate of Analysis (CoA): CA-TH - 0017/17 (homogeneous sample)
Batch nº: 20161215
Test item sent by: Jinxi County Purong Essences MFG Co., Ltd.
Physical state: Liquid
Stability data (a.i.): Stable at room temperature. (1)
Water solubility (a.i.): 7.44 mg•L-1 (20°C, pH 6.7) (1)
Manufacturing date: 15/Dec/2015
Expiry date: 14/Dec/2018
Manufacturer: Jinxi County Purong Essences MFG Co., Ltd.

Study design

Buffers:

pHs 4, 7, 9 and 10 sterilized buffers (buffer solution of pH 10 was used only for calibration of pHmeter);
Ultrapure water (sterilized);
Phosforic acid PA - Purity: 85%;
Acetonitrile HPLC grade - Purity: 99.9%.

Duration of test

Duration of test 1

Duration:

0 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

1.87 mg/L

Duration of test 2

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

0.13 mg/L

Duration of test 3

Duration:

0 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

1.9 mg/L

Duration of test 4

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

1.11 mg/L

Duration of test 5

Duration:

0 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

1.56 mg/L

Duration of test 6

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

0.13 mg/L

Results and discussion

Preliminary study:

A preliminary test was performed at 50.0 ± 0.5oC at pHs 4, 7 and 9 in order to determine the hydrolytic
stability of the test substance under these conditions. The details of the samples preparation are given
in sections 6.7.1 and 6.7.2. The samples were placed in the chamber at 50.0 ± 0.5oC for a period of 5
days. The concentration of the test substance in the solutions was determined by chromatographic
analysis of the samples collected after the preparation of the test solutions and after the incubation of
samples for 5 days at 50 ± 0.5ºC.

Transformation products:

not specified

Dissipation DT50 of parent compound

Key result

pH:

4

Temp.:

50 °C

DT50:

< 1 yr

Type:

(pseudo-)first order (= half-life)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

According to the results of Tier I, the test substance (Gamma terpinene) degraded more than 10% of the
initial concentration at 50 ± 0.5°C at pHs 4, 7 and 9. However, the definitive test (Tier II) is necessary to
determine the stability of Gamma terpinene in function of pH.