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EC number: 220-425-7 | CAS number: 2760-98-7
- 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
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:
- 12 Mar 2018 - 18 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isophthalohydrazide
- EC Number:
- 220-425-7
- EC Name:
- Isophthalohydrazide
- Cas Number:
- 2760-98-7
- Molecular formula:
- C8H10N4O2
- IUPAC Name:
- isophthalohydrazide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: White crystal powder
Test item storage: At room temperature
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and all test concentrations
- Sampling method: 2.0 mL from the approximate centre of the test vessels, at t=0 h and t=48 h.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
- At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with the highest concentration of 100 mg/L applying from 10 to 35 minutes of magnetic stirring to accelerate dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
All test solutions were clear and colorless at the end of the preparation procedure.
- Controls: Test medium without test item or other additives.
- Evidence of undissolved material: The saturated solution prepared for the combined limit/range-finding test was observed to contain undissolved material, which was filtered out using a 0.45 µm membrane filter (RC55, Whatman). It was thus concluded that any undissolved material was not test item related. The solutions for the limit and final tests did not contain any undissolved material.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus 1820
- Source: In-house laboratory culture with a known history
- Age of parental stock: >2 weeks old
- Age at test initiation: <24 hours
- Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
CULTIVATION
- Start of each batch: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of M7 medium in an all-glass culture vessel.
- Maximum age of the cultures: 4 weeks
- Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
- Temperature of medium: 18-22°C
- Feeding: Daily, a suspension of fresh water algae.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L as CaCO3
- Test temperature:
- 20 - 21°C
- pH:
- At start: 7.8
At end (t=48 h): 8.1 - Dissolved oxygen:
- At start: 8.4 - 9.0 mg/L
At end (t=48 h): 8.9 - 9.0 mg/L - Nominal and measured concentrations:
- Nominal: 10, 18, 32, 56, 100 mg/L
Measured concentrations were at the level of nominal throughout the test duration (i.e., 91-103% of nominal concentrations). Based on these results, effects parameters were based on the analytically confirmed nominal concentrations. See Table 1 in 'Any other information on results' for details on measured concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL all-glass with a fill volume of 50 mL
- Aeration: no
- Feeding: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, prepared with tap water purified by Reverse Osmosis
- Culture medium different from test medium: yes, M7 medium
- Intervals of water quality measurement: Dissolved oxygen and pH: at beginning and end of the test, for all test concentrations and the control. Temperature: continuously in a temperature control vessel, beginning at the start of the test.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h photoperiod daily
EFFECT PARAMETERS MEASURED
- Immobility (including mortality) at 24 hours and at 48 hours.
RANGE-FINDING STUDY
A Combined Limit/Range-Finding test and a Limit test were performed prior to the Final test.
- Test concentrations: 0.1, 1.0, 10 and 100% of a saturated solution prepared at 100 mg/L (Combined Limit/Range-Finding test); 0 and 100 mg/L (Limit test).
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate, performed March 2018
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: none observed in the Control group.
- Mortality of control: none
- All water quality parameters remained within the requirements as laid down in the study plan throughout the test.
Immobility at the highest test concentration was observed in all three tests performed (i.e. 25, 70 and 45% immobility in the combined limit/range-finding test, limit test and final test, respectively, at the end of the test), however, only in the limit test the effect was >50%. The observed difference could be due to a difference in sensitivity of the daphnids. Additionally, no toxicity was observed after 24 hours of exposure in any of the tests performed and, in both the combined limit/range-finding test and final test, a high variability in immobility was observed between vessels. This could imply a slightly delay in toxicity around the 48 hours of exposure.
In conclusion, it was decided to base the effects parameters on the results of two out of the three tests, i.e. the combined limit/range-finding test and the final test. - Results with reference substance (positive control):
- - Results with reference substance valid?
Yes
- The 24h-EC50 was 0.80 mg/L with a 95% confidence interval between 0.71 and 0.90 mg/L.
- The 48h-EC50 was 0.33 mg/L with a 95% confidence interval between 0.29 and 0.38 mg/L.
- The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at the Test Facility.
Any other information on results incl. tables
Table 1: Final Test: Test Samples
Time of sampling |
Date of sampling |
Date of |
Concentration |
Relative to nominal |
Relative to initial |
|
Nominal |
Analyzed |
|||||
0 |
07 May 2018 |
18 May 2018 |
0 |
n.d. |
n.a. |
|
|
|
|
10 |
9.36 |
94 |
|
|
|
|
18 |
17.8 |
99 |
|
|
|
|
32 |
31.2 |
97 |
|
|
|
|
56 |
57.5 |
103 |
|
|
|
|
100 |
102 |
102 |
|
48 |
09 May 2018 |
18 May 2018 |
0 |
n.d. |
n.a. |
n.a. |
|
|
|
10 |
9.08 |
91 |
97 |
|
|
|
18 |
17.5 |
97 |
98 |
|
|
|
32 |
30.9 |
96 |
99 |
|
|
|
56 |
56.4 |
101 |
98 |
|
|
|
100 |
102 |
102 |
99 |
# Samples were stored in the freezer (≤ -15°C) until the day of analysis.
n.d. Not detected.
n.a. Not applicable.
Table 2: Number of Introduced Daphnids and Incidence of Immobility
in the Final Test
Time (h) |
Replicate |
Measured concentration (mg/L) |
|||||
Control |
10 |
18 |
32 |
56 |
100 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
|
24 |
A |
0 |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
0 |
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
0 |
0 |
|
Effect % |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
0 |
4 |
B |
0 |
0 |
0 |
0 |
0 |
3 |
|
C |
0 |
0 |
0 |
0 |
0 |
2 |
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
0 |
9 |
|
Effect % |
0 |
0 |
0 |
0 |
0 |
45 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For details on validity criteria, please refer to section 'Overall remarks'.
- Conclusions:
- The 48h-EC50 for Daphnia magna exposed to the test substance was > 100 mg/L based on analytically confirmed nominal concentrations.
- Executive summary:
In a 48 h acute toxicity test conducted according to OECD guideline 202, Daphnia magna were exposed to the test item at nominal concentrations of 10, 18, 32, 56 and 100 mg/L and an untreated control (4 replicates, 5 daphnids per replicate). Measured concentrations were at 91 -103% relative to nominal throughout the test. Therefore, effect parameters were based on nominal concentrations. No immobility was observed in the control and the four lowest test concentrations throughout the test, while 45% effect was observed at the highest concentration after 48 h of exposure. The 48h-EC50 for Daphnia magna exposed to the test item exceeded a nominal concentration of 100 mg/L. The study is considered to be reliable without restrictions.
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