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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

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:

96 h

Dose descriptor:

LC50

Effect conc.:

0.64 mg/L

Remarks on result:

other: MSDS

Validity criteria fulfilled:

not applicable

Conclusions:

The LC50 (96h) is 0.64 mg/L.

Executive summary:

The LC50 (96h) is 0.64 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

calculation (if not (Q)SAR)

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:

96 h

Dose descriptor:

LC50

Effect conc.:

1 743.475 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 (96h) is 1743.475 mg/L.

Executive summary:

The calculated (ECOSAR v1.11, Neutral Organic SAR class) LC50 (96h) is 1743.475 mg/L.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

calculation (if not (Q)SAR)

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:

96 h

Dose descriptor:

LC50

Effect conc.:

778.872 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 (96h) is 778.872 mg/L.

Executive summary:

The calculated (ECOSAR v1.11, Neutral Organic SAR class) LC50 (96h) is 778.872 mg/L.

Reference 4

Endpoint:

fish embryo acute toxicity (FET)

Remarks:

Combined report in which existing fish data gaps were filled with FET screening data for multiple substances

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Collection of OECD236 data for various substances

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 236 (Fish embryo acute toxicity (FET) test)

Version / remarks:

Test conducted in a screening form with limited concentrations and no chemical analysis.

Deviations:

yes

Remarks:

Not GLP, No Chemical analysis

Principles of method if other than guideline:

Screening method used a higher number of Embryos are used per well.

GLP compliance:

no

Remarks:

Study based on the OECD 236 guideline

Specific details on test material used for the study:

Mixture of Peroxydicarbonates :Peroxydicarbonates
CAS/ Batch /Lot 78350-78-4 16041B0206
Hydrolysis Likely Rapid
1,10,100 Daily WAF to allow formation of hydrolysis products
Purity 30% in stabilizer

Analytical monitoring:

no

Remarks:

Hydrolysis very rapid to more stable degradation products

Details on sampling:

N/A

Vehicle:

no

Details on test solutions:

Test solutions
When the solubility and stability of the material was known to be very low WAF (Water accommodated fraction) solutions were made to prepare the test material.

Slow stir WAF preparations have been shown to be capable of producing a stable concentration of dissolved parent material (as well as stabilizing agent or accumulating degradation products) when loaded in excess of the water solubility and slowly stirred in the same manner as a slow stir water solubility test.

Each WAF vessel was equipped with a Teflon tap that allows only the water accommodated fraction to be transferred without the transfer of undissolved material.

The test material for the WAF prepared substances was weighed accurately and added to each WAF vessel separately. The vessels were then carefully filled with 1 liter of test medium and stirred slowly under sealed conditions at room temperature for approximately 72 hours. Prior to the test the stirring was stopped and all WAF vessels were left to rest for 1 hour after which all of the test wells were rinsed with the appropriate test solution to minimize the absorbance of the test material. The test solutions were then discarded and refilled prior to testing. WAF vessels were then restarted and used for the daily refreshment of the solutions in the same manner.

Solution replenishment
Solution refreshment was carried out daily for WAF preparations by removing as much liquid as possible from each well (while avoiding drying of the embryos) using a pipette. After which the appropriate WAF solution was tapped off directly into the test wells. The WAF solutions (in which excess of test material remained visible) were used at the start of the test as well as for all solution replacements.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Embryos arrived 3-4 hpf (hours post fertilization). As soon as the test solutions were made embryos were divided into bulk batches using glass pipettes at the appropriate concentration for each test chemical to prevent delay in exposure caused by preparation time. The wells were then filled with each of the stocks made for each chemical at each concentration. After a maximum of one hour the wells were emptied and refilled, after which the embryos (5 per well) were added. Plates were then incubated for the test duration and observed daily.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

The test medium Dutch Standard Water (DSW) was used for testing. DSW has a , conductivity of 550-650 µS/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 addition of the stocks and continual aeration before being used in the test.

Test temperature:

26ºC +/- 2ºC

pH:

pH of 8.2

Dissolved oxygen:

Continually aerated before use

Salinity:

N/A

Conductivity:

550-650 µS/cm

Nominal and measured concentrations:

1,10,100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Wellplate
- Type: closed
- Material, size, headspace, fill volume: 3ml
- Aeration: No
- Renewal rate of test solution (frequency/flow rate):48h
- No. of organisms per vessel:5
- No. of vessels per concentration (replicates):5
- No. of vessels per control (replicates):6
- No. of vessels per vehicle control (replicates):6

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

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

TEST CONCENTRATIONS

- Justification for using less concentrations than requested by guideline: screening (fish data not compulsory at registered tonnage)

Reference substance (positive control):

yes

Remarks:

Internal positive and negative controls acceptable

Duration:

96 h

Dose descriptor:

EL50

Effect conc.:

> 10 - < 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Degraded material

Basis for effect:

coagulation of the embryo

Results with reference substance (positive control):

Acceptable according to guideline

Reported statistics and error estimates:

Range estimated in comparison to control only

Validity criteria fulfilled:

yes

Remarks:

With restrictions Not GLP and No Chemical analysis. Endpoint is currently not needed for existing tonnage. Valid therefore as supporting evidence.

Conclusions:

An estimation of the EL50 for adult fish species was made for the material tested. The validity criteria were primarily met and where this was not the case this was justified accordingly. The embryo batches were considered of good quality and sufficient for use in the OECD236 test.

Executive summary:

Guideline study in simplified screening form without GLP and without chemical analysis. Required validity and reference criteria were met. Indicated toxicity range corresponds with current available data for Daphnia and Algae. Material is rapidly degrading to more stable degredation products and contains stabilizer/solvent. Data considered an acceptable nominal estimation for the marketed product.

Description of key information

The endpoint is fulfilled using Weight of Evidence. An OECD 236 (FET) study of the Reaction mass of bisisopropyl peroxydicarbonate and bis-sec-butyl peroxydicarbonate and isopropylsecbutylperoxydicarbonate gave a 96h-LC50 between 10 and 100 mg/L loading rate.

It was demonstrated that the organic peroxides 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 LC50 for fish for this substance is 0.64 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 shows less toxicity than that of the stabilizer.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.64 mg/L