Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-782-3 | CAS number: 6731-36-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to soil microorganisms
Administrative data
- Endpoint:
- toxicity to soil microorganisms
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date 23 January 2017 Experimental completion date 20 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.21 (Soil Microorganisms: Nitrogen Transformation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
- EC Number:
- 229-782-3
- EC Name:
- Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
- Cas Number:
- 6731-36-8
- Molecular formula:
- C17H34O4
- IUPAC Name:
- 1,1-bis(tert-butylperoxy)-3,3,5-trimethylcyclohexane
- Reference substance name:
- Trigonox® 29
- IUPAC Name:
- Trigonox® 29
- Reference substance name:
- 0905137109
- IUPAC Name:
- 0905137109
- Details on test material:
- Identification: Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
CAS Number: 6731-36-8
Trade Name: Trigonox® 29
Batch Number: 0905137109
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Identification: Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
CAS Number: 6731-36-8
Physical state/Appearance: clear colorless viscous liquid
Batch: 0905137109
Purity: 93.4%
Expiry Date: 01 June 2019
Storage Conditions: approximately 4 ºC in the dark
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The samples were transferred to polyethylene bottles and an aliquot (250 mL) of potassium chloride (0.1M) added. The mixtures were then shaken (200 rpm, for between 33 and
35 minutes) using an INFORS TR-225 orbital platform shaker prior to removal of the aqueous phase by filtration (0.45 µm AcroCap filter).
Test substrate
- Vehicle:
- yes
- Remarks:
- Acetone
- Details on preparation and application of test substrate:
- The test item was prepared in a preliminary solvent stock solution. All test concentrations were corrected for a purity value of 93.4%.
Nominal amounts of test item (1713 and 5353 mg) were separately dissolved in acetone and the volumes adjusted to 10 mL to give 1713 mg/10 mL and 5353 mg/10 mL solvent stock solutions respectively equivalent to 1600 mg ai/10 mL and 5000 mg ai/10 mL solvent stock solutions. Serial dilutions from the 5000 mg ai/10 mL solvent stock solution were made to give 500 and 50 mg ai/10 mL stock solutions.
Additionally, a serial dilution from the 1600 mg ai/10 mL solvent stock solution was made to give a 160 mg ai/10 mL solvent stock solution.
Aliquots (1 mL) of each of the solvent stock solutions were dispensed separately onto dry quartz sand (5 g) and the solvent allowed to evaporate to dryness. The test item/sand combination and an amount of powdered Lucerne-green-grass-meal*** (2.5 g) was then added to a final bulk soil weight of 500 g* and thoroughly mixed (Kenwood Chef Mixer) for 2 minutes prior to the addition of an aliquot (50.4 mL) of water and further mixing for 10 minutes to give the required test concentrations of 10, 32, 100, 320, 1000 mg ai/Kg with a nominal moisture content of 45% of the Water Holding Capacity (WHC). Three 50 g* aliquots were then taken for Day 0 analysis. The remaining soil bulk was incubated in amber glass jars.
The test item was prepared in a preliminary solvent stock solution. All test concentrations were corrected for a purity value of 93.4%.
Nominal amounts of test item (1713 and 5353 mg) were separately dissolved in acetone and the volumes adjusted to 10 mL to give 1713 mg/10 mL and 5353 mg/10 mL solvent stock solutions respectively equivalent to 1600 mg ai/10 mL and 5000 mg ai/10 mL solvent stock solutions. Serial dilutions from the 5000 mg ai/10 mL solvent stock solution were made to give 500 and 50 mg ai/10 mL stock solutions. Additionally, a serial dilution from the 1600 mg ai/10 mL solvent stock solution was made to give a 160 mg ai/10 mL solvent stock solution.
Aliquots (1 mL) of each of the solvent stock solutions were dispensed separately onto dry quartz sand (5 g) and the solvent allowed to evaporate to dryness. The test item/sand combination and an amount of powdered Lucerne-green-grass-meal*** (2.5 g) was then added to a final bulk soil weight of 500 g* and thoroughly mixed (Kenwood Chef Mixer) for 2 minutes prior to the addition of an aliquot (50.4 mL) of water and further mixing for 10 minutes to give the required test concentrations of 10, 32, 100, 320, 1000 mg ai/Kg with a nominal moisture content of 45% of the Water Holding Capacity (WHC). Three 50 g* aliquots were then taken for Day 0 analysis. The remaining soil bulk was incubated in amber glass jars.
Test organisms
- Test organisms (inoculum):
- soil
Study design
- Total exposure duration:
- 28 d
Test conditions
- Test temperature:
- Room temperature was recorded daily throughout the test. Temperature was maintained at temperatures of between 21 and 22 ºC throughout the test
- Moisture:
- Each individual test vessel was weighed on Day 0 and deionized reverse osmosis water added on a weight basis on Days 7, 14, 21 and 28 in order to maintain the moisture content within ±5% of the initial moisture content.
The moisture content of each control, solvent control and test vessel was adjusted to 45% of the WHC (± 5%) of the soil on days 7, 14, 21 and 28 - Details on test conditions:
- The soil for the study was obtained on 15 December 2016 from LUFA Speyer, Germany. The sampling site had not been treated with crop protection products or organic fertilizer for at least 3 years prior to sampling (data from supplier).
The pH of the soil in water was 7.6 (information supplied by LUFA Speyer). The organic carbon content was determined to be 0.67 ± 0.03% whilst the sand content of the soil was determined to be 57.5% (information supplied by LUFA Speyer.
The microbial biomass of the soil was shown to be 16.19 C/g (ISO 14240-2, 1997). This was equivalent to 2% of the total soil organic carbon content.
The total nitrogen content of the soil was 76 mg/100 g (information supplied by LUFA Speyer, see Annex 2) and the initial nitrate content of the soil determined on the day the test was initiated was 6.4 mg/100 g.
Experimental Design and Study Conduct
Preparation of Soil
On arrival at Envigo Research Limited, Shardlow, UK the soil was stored at temperatures of between 4 and 12 ºC prior to use. Prior to the start of the test, an amount of soil (approximately 11 kg) was removed and stored at temperatures of between 20 and 21 ºC for 12 days and shielded from light.
The moisture content of the soil was determined prior to the start of the test by drying an amount of soil (100 g) at 105 C (± 10%) until a constant weight was obtained. The moisture content of the soil, expressed as a percentage of the dry weight, was determined to be 6%. The Water Holding Capacity (WHC) of the soil supplied by LUFA Speyer was 35.6 g/100 g ± 1.4 and hence 50.4 mL of deionized reverse osmosis water per 0.5 kg* of soil was added. This gave a final water content of 15.5 g/100 g**, i.e. 45% of the WHC as recommended by the Test Guidelines.
6 replicates per concentration - Nominal and measured concentrations:
- 10, 32, 100, 320 and 1000 mg ai/kg
- Reference substance (positive control):
- yes
- Remarks:
- A positive control (Envig: SD86WH) used 2-Chloro-6-(trichlormethyl)pyridine as the test item at concentrations of 0.10, 1.0 and 10 mg/kg. Exposure conditions and data evaluation for the positive control were similar to those in the definitive test.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 28 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- nitrate formation rate
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- nitrate formation rate
- Details on results:
- Validation Criteria
The variation between replicate solvent control nitrification rates was less than 15% and therefore satisfied the validation criterion given in the Test Guidelines.
Environmental Measurements
Temperature was maintained at temperatures of between 21 and 22 ºC throughout the test and the moisture content of each control, solvent control and test vessel was adjusted to 45% of the WHC (± 5%) of the soil on days 7, 14, 21 and 28.
Nitrogen Transformation Activity
The effect of the test item on the nitrogen transformation activity of the soil microorganisms gave an EC50 of greater than 1000 mg ai/Kg. The No Observed Effect Concentration (NOEC) after 28 days exposure was 1000 mg ai/Kg. - Results with reference substance (positive control):
- Positive Control
A positive control (Envigo Research Limited, Study Number: SD86WH) used 2-Chloro-6-(trichlormethyl)pyridine as the test item at concentrations of 0.10, 1.0 and 10 mg/kg.
Exposure conditions and data evaluation for the positive control were similar to those in the definitive test.
Exposure of the soil to the test item gave the following results:
EC10 : 1.2 mg/kg
EC16 : 1.7 mg/kg
EC50 : 3.9 mg/kg, 95% confidence limits 3.5 – 4.4 mg/kg
EC80 : 7.0 mg/kg
The results from the positive control with 2-Chloro-6-(trichlormethyl)pyridine were within the normal ranges for this test item.
Any other information on results incl. tables
Absorbance Values and Nitrate Concentration Values
Nominal Concentration (mg ai/kg) |
Day 0 |
|
Nominal Concentration (mg ai/kg) |
Day 0 |
||||
Absorbance*(324 nm) |
Nitrate Concentration (mg NO3/kg) |
|
Absorbance* |
Nitrate Concentration (mg NO3/kg) |
||||
Control |
R1 |
0.2738 |
93.60 |
|
320 |
R1 |
0.2912 |
99.50 |
R2 |
0.2751 |
94.05 |
|
R2 |
0.2988 |
102.05 |
||
R3 |
0.2800 |
95.70 |
|
R3 |
0.2930 |
100.10 |
||
Mean |
- |
94.45 |
|
Mean |
- |
100.55 |
||
SD |
- |
1.11 |
|
SD |
- |
1.33 |
||
CV% |
- |
1.18 |
|
CV% |
- |
1.32 |
||
Solvent Control |
R1 |
0.2829 |
96.70 |
|
1000 |
R1 |
0.2903 |
99.20 |
R2 |
0.2919 |
99.75 |
|
R2 |
0.2928 |
100.05 |
||
R3 |
0.2717 |
92.90 |
|
R3 |
0.3025 |
103.30 |
||
Mean |
- |
96.45 |
|
Mean |
- |
100.85 |
||
SD |
- |
3.43 |
|
SD |
- |
2.16 |
||
CV% |
- |
3.56 |
|
CV% |
- |
2.14 |
||
10 |
R1 |
0.2992 |
102.20 |
|
|
|
|
|
R2 |
0.3048 |
104.10 |
|
|
|
|
|
|
R3 |
0.3010 |
102.80 |
|
|
|
|
|
|
Mean |
- |
103.03 |
|
|
|
|
|
|
SD |
- |
0.97 |
|
|
|
|
|
|
CV% |
- |
0.94 |
|
|
|
|
|
|
32 |
R1 |
0.3119 |
106.50 |
|
|
|
|
|
R2 |
0.3098 |
105.75 |
|
|
|
|
|
|
R3 |
0.3179 |
108.50 |
|
|
|
|
|
|
Mean |
- |
106.92 |
|
|
|
|
|
|
SD |
- |
1.42 |
|
|
|
|
|
|
CV% |
- |
1.33 |
|
|
|
|
|
|
100 |
R1 |
0.3137 |
107.10 |
|
|
|
|
|
R2 |
0.3182 |
108.60 |
|
|
|
|
|
|
R3 |
0.3054 |
104.30 |
|
|
|
|
|
|
Mean |
- |
106.67 |
|
|
|
|
|
|
SD |
- |
2.18 |
|
|
|
|
|
|
CV% |
- |
2.04 |
|
|
|
|
|
Table 1 (continued) Absorbance Values and Nitrate Concentration Values
Nominal Concentration (mg ai/kg) |
Day 28 |
|
Nominal Concentration (mg ai/kg) |
Day 28 |
||||
Absorbance*(324 nm) |
Nitrate Concentration (mg NO3/kg) |
|
Absorbance* |
Nitrate Concentration (mg NO3/kg) |
||||
Control |
R4 |
0.6972 |
236.70 |
|
320 |
R4 |
0.6251 |
212.35 |
R5 |
0.6475 |
219.90 |
|
R5 |
0.6033 |
204.95 |
||
R6 |
0.5964 |
202.65 |
|
R6 |
0.6500 |
220.75 |
||
Mean |
- |
219.75 |
|
Mean |
- |
212.68 |
||
SD |
- |
17.03 |
|
SD |
- |
7.91 |
||
CV% |
- |
7.75 |
|
CV% |
- |
3.72 |
||
Solvent Control |
R4 |
0.6738 |
228.80 |
|
1000 |
R4 |
0.6262 |
212.70 |
R5 |
0.6599 |
224.10 |
|
R5 |
0.6154 |
209.05 |
||
R6 |
0.5907 |
200.70 |
|
R6 |
0.6692 |
227.25 |
||
Mean |
- |
217.87 |
|
Mean |
- |
216.33 |
||
SD |
- |
15.05 |
|
SD |
- |
9.63 |
||
CV% |
- |
6.91 |
|
CV% |
- |
4.45 |
||
10 |
R4 |
0.6829 |
231.85 |
|
|
|
|
|
R5 |
0.6870 |
233.25 |
|
|
|
|
|
|
R6 |
0.6305 |
214.15 |
|
|
|
|
|
|
Mean |
- |
226.42 |
|
|
|
|
|
|
SD |
- |
10.65 |
|
|
|
|
|
|
CV% |
- |
4.70 |
|
|
|
|
|
|
32 |
R4 |
0.6563 |
222.85 |
|
|
|
|
|
R5 |
0.6546 |
222.30 |
|
|
|
|
|
|
R6 |
0.6478 |
220.00 |
|
|
|
|
|
|
Mean |
- |
221.72 |
|
|
|
|
|
|
SD |
- |
1.51 |
|
|
|
|
|
|
CV% |
- |
0.68 |
|
|
|
|
|
|
100 |
R4 |
0.6841 |
232.25 |
|
|
|
|
|
R5 |
0.6340 |
215.35 |
|
|
|
|
|
|
R6 |
0.6535 |
221.90 |
|
|
|
|
|
|
Mean |
- |
223.17 |
|
|
|
|
|
|
SD |
- |
8.52 |
|
|
|
|
|
|
CV% |
- |
3.82 |
|
|
|
|
|
Table2 Inhibition of Nitrogen Transformation Activity
Nominal Concentration |
Day 28 |
|
Nitrate Formation Rate |
% Inhibition |
|
Control |
4.48 |
- |
Solvent Control |
4.34 |
- |
10 |
4.41 |
[2] |
32 |
4.10 |
6 |
100 |
4.16 |
4 |
320 |
4.00 |
8 |
1000 |
4.12 |
5 |
*Corrected for blank absorbance value
R1-R3= Replicates 1 to 3
SD = Standard Deviation
CV = Coefficient of Variation
*Corrected for blank absorbance value
R4– R6= Replicates 4 to 6
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Executive summary:
Introduction
A study was performed to assess the long-term effect of the test item, after a single exposure, on the nitrogen transformation activity of soil microorganisms.
Methods
Soil microorganisms were exposed to the test item at concentrations of 10, 32, 100, 320 and 1000 mg active ingredient(ai)/kg for 28 days at temperatures of between 21 and 22 °C in the dark with the addition of powdered Lucerne-green-grass meal to act as a respiratory substrate.
The inhibitory effect of the test item on nitrogen transformation was assessed by the determination of nitrate concentration in the soil samples on Days 0 and 28 and compared to data obtained from solvent control soil samples.
Results
The effect of the test item on the nitrogen transformation activity of the soil microorganisms gave an EC50of greater than 1000 mg ai/kg. The No Observed Effect Concentration (NOEC) was1000 mg ai/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.