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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1st September 2015 - 15th December 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A well conducted study according to guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction Mass of Mixed Xylenes and Sulphur Monochloride
IUPAC Name:
Reaction Mass of Mixed Xylenes and Sulphur Monochloride
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Batch 46000058
- Purity test date: Not applicable; substance is a UVCB


OTHER SPECIFICS:
Due to the low water solubility of the test item, a modification to the standard method of preparation for aqueous media was performed. The organisms were exposed to a Water Accommodated Fraction (WAF), as accepted by many regulatory authorities in the EU (ECETOC 1996, OECD 2000 and Singer et al 2000). Aqueous media are prepared by mixing test item with water for a prolonged period, the solution is left to settle and the test item phase siphoned off. The test organisms are exposed to the aqueous phase or WAF, containing dissolved test item and leachates from the test item. Exposure is expressed in terms of the original concentration of test item in water at the start of the mixing period irrespective of the dissolved fraction.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the test solution at 0 and 48 hours for quantitative analysis

Test solutions

Vehicle:
yes
Details on test solutions:
An amount of test material (200 mg) was added to the surface of 2 litres of test water to give 100mg/L loading rate. The Water Accommodated Fraction (WAF) was prepared over 23 hours. The WAF removed from mid-depth.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source:Envigo Research Limited in-house laboratory cultures.
- Age at study initiation (mean and range, SD): < 24hours

ACCLIMATION
- Acclimation period: Not relevant
- Type and amount of food: Daily Algal suspension (Desmodesmus subspicatus) and Tetramin flake food.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Test temperature:
21 - 22°C
pH:
8.0-8.1
Dissolved oxygen:
8.8 - 8.9 mg O2/l
Nominal and measured concentrations:
Nominal concentration 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 ml glass jar
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates): 4
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mobility
Details on results:
The cumulative immobilisation data and observations made in the definitive test are presented in tables 1 and 2 below.

Table 1. 24 hour data
Cumulative Immobilised Daphnia
Nominal Loading Rate (mg/L) (Initial population: 5 per replicate) Observations
R1 R2 R3 R4 Total % R1 R2 R3 R4
Control 0 0 0 0 0 0 5 N 5 N 5 N 5 N
100 0 0 0 0 0 0 5 N 5 N 5 N 5 N

Table 2. 48 hour data

Cumulative Immobilised Daphnia
Nominal Loading Rate (mg/L) (Initial population: 5 per replicate) Observations
R1 R2 R3 R4 Total % R1 R2 R3 R4
Control 0 0 0 0 0 0 5 N 5 N 5 N 5 N
100 0 0 0 0 0 0 5 N 3 N,2T 2 N, 3T 3 N, 2T

R1 –R4: Replicates 1 -4
N: No sub-lethal effects observed
T: Trapped at surface

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48 hour EL50 of 'Reaction mass of mixed xylenes and sulphur monochloride' in Daphnia magna was >100mg/L mg/l. The NOELR was 100 mg/l.
Executive summary:

A GLP study was performed to assess the acute toxicity of 'Reaction mass of mixed xylenes and sulphur monochloride' to Daphnia Magna in accordance with OECD 202. Following a preliminary range-finding study, twenty daphnids (4 replicates of 5 animals) were exposed to aqueous dispersions of the test substance at concentrations of 0 and 100 mg/l for 48 hours under static test conditions. The numbers of immobilised Daphnia were recorded after 24 and 48 hours.

From the results of the test, the 48 hour EL50 for the test material was determined to be > 100 mg/L, based on nominal test concentrations. The No Observed Effect Loading Rate was 100 mg/L.