Reaction mass of bisisopropyl peroxydicarbonate and bis-sec-butyl peroxydicarbonate and isopropyl-secbutylperoxydicarbonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

not specified

Remarks:

SDS

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Principles of method if other than guideline:

no data

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 10 - <= 100 mg/L

Remarks on result:

other: MSDS

Validity criteria fulfilled:

not applicable

Conclusions:

The EC50 (48h) falls between 10-100 mg/L.

Executive summary:

The EC50 (48h) falls between 10-100 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

calculation (if not (Q)SAR)

Remarks:

ECOSAR v1.11

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Principles of method if other than guideline:

calculation

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

844.305 mg/L

Remarks on result:

other: ECOSAR v1.11 calculation: Neutral Organics SAR Class

Validity criteria fulfilled:

not applicable

Conclusions:

The calculated (ECOSAR v1.11, Neutral Organic SAR class) LC50 (48h) is 844.305 mg/L.

Executive summary:

The calculated (ECOSAR v1.11, Neutral Organic SAR class) LC50 (48h) is 844.305 mg/L.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

calculation (if not (Q)SAR)

Remarks:

ECOSAR v1.11

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Principles of method if other than guideline:

calculation

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

394.678 mg/L

Remarks on result:

other: ECOSAR v1.11 calculation: Neutral Organics SAR Class

Validity criteria fulfilled:

not applicable

Conclusions:

The calculated (ECOSAR v1.11, Neutral Organic SAR class) LC50 (48h) is 394.678 mg/L.

Executive summary:

The calculated (ECOSAR v1.11, Neutral Organic SAR class) LC50 (48h) is 394.678 mg/L.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Remarks:

Screening study on the multiconstituent product

Type of information:

experimental study

Remarks:

Screening study

Adequacy of study:

weight of evidence

Study period:

9-10-2017-11-10-2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

According to OECD 202 adapted for screening purposes

Justification for type of information:

OECD 202 guideline was followed and a certificate of analysis was included. Algae study has demonstrated equal toxicity in tests prepared from a stock in the traditional manner and aged material prepared by a water accommodated fraction method (WAF method). A WAF method only was therfore conducted in this screening study. No chemical analysis was conducted and the study was not conducted to GLP. Test material is a multi constituent substance in stabilizer and toxicity endpoint is therefore an indication of Nominal toxicity of the product. Due to the stable component of the material likely being the cause of the toxicity the lack of chemical analysis is not considered a critical restriction.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

Less replicates no analysis

Principles of method if other than guideline:

Degraded material tested due to instability of parent and hydrolytical halflife of likely <12h

GLP compliance:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16041B0206
- Expiration date of the lot/batch:10/1/2018
- Purity test date: 28-30%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:-20ºC
- Stability under test conditions: highly instable
- Solubility and stability of the test substance in the solvent/vehicle: low
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: possible

Analytical monitoring:

no

Details on sampling:

N/A

Vehicle:

no

Details on test solutions:

Stock solutions were not made in the normal manner due to the poor stability rapid degradation and the fact the test material was a mixture. A water accommodated fraction approach was used in order to test the resulting mixture at corresponding solubility’s of its components and stabilizer.


Test concentrations
1.0 10.0 and 100.0 mg/L were weighed separately into Duran bottles containing 1 L of test medium and equipped with a Teflon taps (WAF Flasks). After 48 hours slow stir the water accommodated fraction was removed and tested directly. A control without test substance was prepared in an identical manner using test medium only.


Determination of immobilization
At 24 and 48 hours the test replicates were observed for immobilization. Animals that were not able to swim freely for at least 15 seconds after gentle agitation were considered immobile.

Test organisms (species):

Daphnia magna

Details on test organisms:

Juvenile daphnids of D. magna, Clone 5, less than 24 hours old were exposed to various concentrations of these test substances over a period of 48 hours under defined conditions. The ability of the test animals to swim freely in the test media was assessed at 24 and 48 hours in Dutch standard water.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

According to guideline

Post exposure observation period:

N/A

Hardness:

The test medium Dutch Standard Water (DSW) was used for testing. DSW has a pH of 8.2, conductivity of 550-650 µsS/cm, and contains: 200 mg of CaCl2·2H2O, 180 mg of MgSO4·7H2O, 100 mg of NaHCO3 and 20 mg of KHCO3 per liter. The water was made by an automatic dosing system and was aerated for at least 30 minutes before being used in the test. Quality and acceptance of the DSW was covered in the routine laboratory maintenance.

Test temperature:

20+/- 2ºC

pH:

8-8.2

Dissolved oxygen:

7-8 mg/L

Salinity:

N/A

Conductivity:

550-650 µsS/cm

Nominal and measured concentrations:

1,10 and 100 mg/L loading rate.

Details on test conditions:

TEST SYSTEM
- Test vessel: 50ml glass beaker
- Type (delete if not applicable): open
- Aeration: prior to study not during

- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates)2:
- No. of vessels per control (replicates):4
- No. of vessels per vehicle control (replicates):N/A


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic according to SOP made in Deionised water.The concentrations cited in this report refer to the as-received samples. All chemicals used were of reagent grade. De-ionized water containing no more than 0.01 mg/L of Cu, TOC content of <2.0 mg/Ll and a conductivity of <10 µS/cm, was prepared by the site water purification system.
-
OTHER TEST CONDITIONS
- Adjustment of pH: not required
- Photoperiod:16:8 day/light
- Light intensity: 10-15 µmol/s-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : every 24 hours

VEHICLE CONTROL PERFORMED: no

Reference substance (positive control):

yes

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

55 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other:

Remarks:

WAF (Mixture)

Details on results:

Test is a good indication of the approximate stabilizer and degradation product toxicity to D.Magna parent rapidly decomposes at 0ºC and hence degradation products are the most relevant for testing.

Results with reference substance (positive control):

Animals used were reference tested twice anually and only used if compliant with laboratory SOP's

Reported statistics and error estimates:

Linear interpolation was used due to lack of partial responses and widely spaced concentrations.

Validity criteria fulfilled:

yes

Remarks:

With restrictions

Conclusions:

The study can be considered reliable as supporting evidence with the restrictions mentioned.

Executive summary:

The study was conducted according to the basis of the OECD 202 guideline with acceptable test material identification information. Study lacked GLP and chemical analysis. It is likely that rapid degradation has taken place and that toxicity was caused by the stabilizing agent and/or degradation products as indicated in the algae study. Data can be used to indicate the nominal toxicity of the product as a whole and is considered valid as supporting evidence when accompanyied by an additional endpoint for invertebrate toxicity for a relevant or closely related substance. Due to the stable component of the material likely being the cause of the toxicity the lack of chemical analysis is not considered a critical restriction.

Description of key information

The endpoint is fulfilled using Weight of Evidence. An OECD 202 study of the Reaction mass of bisisopropyl peroxydicarbonate and bis-sec-butyl peroxydicarbonate and isopropylsecbutylperoxydicarbonate

gave a 48h-EC50 of 55 mg/L loading rate.

It was demonstrated that the organic peroxides present in the Reaction mass rapidly hydrolyze (see 5.1.2) to Isopropanol (CAS 67 -63 -0) and Sec-butanol (CAS 78 -92 -2). The ECOSAR acute endpoints for the hydrolysis byproducts are all > 100 mg/L.

The stabilizing agent (CAS 142 -22 -3) present in the test material does not show rapid hydrolysis. The EC50 for invertebrates for this substance falls between 10 and 100 mg/L.

It is assumed that effects seen in the test with the Reaction mass are caused by the stabilizing agent.

The test result obtained with the Reaction mass is in line with that of the stabilizer.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

55 mg/L