Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2017 - 24 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
- 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
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: approx. 327.4 -361.9 mg per cornea
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount applied: 750 µl per cornea
Concentration: 20% (w/v) Imidazole
- Duration of treatment / exposure:
- 240 ± 10 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by incubation in cMEM. Then, corneas were incubated in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C).
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: catgeory 1);
For a test substance that induces an IVIS >3 and ≤ 55, no prediction on irritant potency can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Single run
- Value:
- -1.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The individual in vitro irritancy scores for the negative controls ranged from 1.3 to 3.7. The individual positive control in vitro irritancy scores ranged from 97 to 158. The corneas treated with the positive control were turbid after the 240 minutes of treatment. The corneas treated with IDH showed opacity values ranging from -3.0 to -1.6 and permeability values ranging from 0.013 to 0.063. The corneas clear after the 240 minutes of
treatment with IDH. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -2.8 to -0.8 after 240 minutes of treatment with IDH.
See table for mean scores
Any other information on results incl. tables
Table: Summary of Opacity, Permeability and In Vitro Scores
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score[1],[2] |
Negative control |
2.1 |
0.014 |
2.4 |
Positive control |
95 |
2.802 |
137 |
IDH |
-2.3 |
0.042 |
-1.7 |
[1]Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
[2]In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline 437 and GLP principles, it is concluded that IDH is not irritant or corrosive for the eye and does not need to be classified.
- Executive summary:
A Bovine Corneal Opacity and Permeability test (BCOP) was performed with IDH according to OECD guideline 437 and GLP principles. IDH was applied undiluted (750 µL/ cornea, n=3). The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 137, and the mean in vitro irritancy score of the negative control (physiological saline) was 2.4. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. IDH did not induce ocular irritation through opacity or permeability, resulting in a mean in vitro irritancy score of -1.7 after 240 minutes of treatment. Since IDH induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.