Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

23 September 2012 - 22 October 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted acording to OECD and EC test guidelines and in compliance with GLP; on this basis the data is considered reliable without restrictions.

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Common functional groups and similar composition.

EP-4000s and the registered substance are very similar. They are UVBC substances and both are oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane where constituents are structurally related. EP-4000s contains less than 0.1% monochlorinated constituents while the registered substance contains approximately 10% monochlorinated constituents. As these are otherwise structurally similar to other constituents it can be reasonably expected that EP-4000s and the registered substance will have essentially the same properties.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

EP4000s:
Purity 79.7-90%, 3 main components F, E, C
Impurities:
5 known by-products 18%
6 unknown impurities 2.4%
Water 0.1%
Chlorinated impurities <0.1%

Aliphaticdiol diglycidyl ether:
Purity 92.57%, 3 main components F, E, C
Impurities:
5 known by-products (same identity as EP-400s) 14.37%
Water none
Two new impurities (I and J) 10.48% in total

Further details are provided in Section 13 Assessment Reports

3. ANALOGUE APPROACH JUSTIFICATION

EP-4000s was tested and found to be not readily biodegradable. The introduction of one chlorine atom to the chemical structure will not affect the biodegradation properties as the molecular backbone of the components are still the same. Furthermore, there was 0% biodegradation over 28 days for EP-4000s, so even if the chlorinated portion of the mixture did biodegrade completely, the 60% degradation criteria would still not be passed.

Conclusion – no new information would be gained by test Aliphaticdiol diglycidyl ether for ready biodegradability – accept classification as not readily biodegradable.

4. DATA MATRIX

Not applicable – read across based on close similarity of composition.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 4.27, 9.39, 20.7, 45.5, and 100 mg/L

The test concentrations of EP-4000S were measured using a Mass Spectrometric method of analysis. At the start of the definitive test, two samples (10 mL) were taken from the freshly-prepared control and test media. After 48 hours, the contents of the test vessels from each group were pooled and further samples were taken for analysis.
On each occasion, one of the samples was analysed and the other was stored in a freezer in case further analysis was required.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
At each concentration, an aliquot of the test substance (nominally 21.0 mg in 5L, 19.0 mg in 2L, 20.7, 45.5 or 100 mg in 1L) was dispersed in dilution medium in glass aspirators. The contents were stirred for approximately 24 hours in the dark and then left to stand for approximately 48 hours in the dark. An aliquot (ca. 500 mL) was then removed from the mid-vessel region of each aspirator to provide a Water Accommodated Fraction (WAF) at each nominal loading rate of 4.27, 9.39, 20.7, 45.5 and 100 mg/L, that were used as the test media.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Straus
- Age at study initiation (mean and range, SD): Less than 24 hours
- Method of breeding: Parthenogenesis

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

239 mg/L CaCO3

Test temperature:

20.8 - 21.1°C

pH:

7.74 - 8.43

Dissolved oxygen:

96 - 100% Air Saturation Value

Nominal and measured concentrations:

Nominal: 0 (control), 4.27, 9.39, 20.7, 45.5, and 100 mg/L
Measured: 0, 1.78, 3.01, 6.26, 6.84, and 7.38 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass dishes
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 mL medium used per dish
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 (20 daphnia total per concentration)
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light: 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation, measured at 24 and 48 hours

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.00, 10.0, and 100 mg/L. 20% Immobilisation seen at 100 mg/L after 48 hours; no immobilisation seen at 1.00 or 10.0 mg/L.
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

26.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limits: 20.5, 33.8 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

9.39 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6.28 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limits: 5.69, 6.54 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

3.01 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: At all concentrations, test media were reported to be colourless.

Validity criteria fulfilled:

yes

Conclusions:

In terms of the mean measured concentrations, the 48-hour EC50 of substance, for the immobilisation of Daphnia magna was, 6.28 mg/L (95% confidence limits of 5.69 and 6.54 mg/L) and the ‘no-observed effect concentration’ was 3.01 mg/L.

Description of key information

EC50, 48 hours (Daphnia Magna) = 6.28 mg/L (measured concentration)

NOEC, 48 hours (Daphnia Magna) = 3.01 mg/L (measured concentration)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

6.28 mg/L

Additional information

A test of the acute toxicity to aquatic invertebrates was conducted on EP-4000S (Huntingdon Life Sciences, 2012, Study CVJ0132). The study was conducted according to OECD Test Guideline 202 and EC Guideline C2; the study was conducted in compliance with GLP.

The 48-hour immobilisation EC₅₀ in Daphnia Magna was found to be 6.28 mg/L and the No-Observed Effect Concentration (NOEC) was 3.01 mg/L: these effect levels are reported in terms of the measures (analytical) concentrations; the fortified or nominal EC₅₀ and NOEC were 26.3 mg/L and 9.39 mg/L, respectively.

The test results for EP-4000s will be read across to Aliphaticdiol diglycidyl ether.

Justification for read across justification - EP-4000s and Aliphaticdiol diglycidyl etherare very similar substances. They are UVBC subtances and both are oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane where consituents are structurally related. EP-4000s contains less than 0.1% monochlorinated consitiuents while Aliphaticdiol diglycidyl ethercontains approximately 10% monochlorinated constituents, but as these are otherwise structurally similar to other constituents it can be reasonably expected that EP-4000s and Aliphaticdiol diglycidyl ether will have essentially the same physicochemcial properties.