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EC number: 855-780-2 | CAS number: 3710-31-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2017-12-09
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- 2010-10-09
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- heptane-1,2-diol
- EC Number:
- 855-780-2
- Cas Number:
- 3710-31-4
- Molecular formula:
- C7H16O2
- IUPAC Name:
- heptane-1,2-diol
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: 14 month old donor cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Number of animals: Not indicated, but 9 corneae in total were used
- Characteristics of donor animals: 14 month old donor cattle
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were stored in HBSS containing 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled slaughter-house and during transportation on the same morning to the laboratory using a Styrofoam box. The corneae were isolated on the same day after delivery of the eyes.
- Time interval prior to initiating testing: On the same day the cattle was slaughtered
- Indication of any existing defects or lesions in ocular tissue samples: All eyes were carefully examined macroscopically for defects.
- Indication of any antibiotics used: 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) were used in the storage solution and incubation medium
- Selection and preparation of corneas: Only intact corneas were selected, those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea.
- Quality check of the isolated corneas: Only corneae with a value of the basal opacity < 7 were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.75 mL
- Concentration: The neat test substance was used. - Duration of treatment / exposure:
- Ten minutes (± 30 seconds)
- Duration of post- treatment incubation (in vitro):
- 210 minutes (120 minutes until the second second opacity reading, another 90 minutes until permeability measurements)
- Number of animals or in vitro replicates:
- 3 corneas per test item/positive control/negative control
- Details on study design:
- NUMBER OF REPLICATES: Three replicates
NEGATIVE CONTROL USED: Saline (0.9% NaCl in deionised water)
POSITIVE CONTROL USED: 2-Ethoxyethanol (purity: 99%)
APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL of the neat test item
TREATMENT METHOD: Not indicated
POST-INCUBATION PERIOD: Yes, 210 minutes
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least three times or more until phenol red was still discoloured (yellow or purple), or the test item was still visible. Once the medium was free of test item, the corneas were given a final rinse with cMEM without phenol red.
- POST-EXPOSURE INCUBATION: In cMEM at 32 ± 1 °C for further two hours in a vertical position
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Using an opacitometer (OP_KiT opacitometer, Electro Design, 63-Riom France). The opacity of each of the corneae was determined by reading each holder placed in the photoreceptor compartment for treated cornea.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader at OD490
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Decision criteria as indicated in the TG were used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of three eyes
- Value:
- 64.55
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, the test item is serious eye damaging (CLP/EPA/GHS (Cat 1).
- Executive summary:
This GLP compliant in vitro study according to OECD guideline 437, was performed to assess the corneal damage potential of the test item by means of the BCOP assay using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item, the positive, and the negative controls were applied to the different corneae and incubated for 10 minutes at 32 ± 1 °C. After the incubation phase, the test item as well as the positive and the negative controls were each rinsed from the corneae. Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in incubation medium, and opacity was measured for a second time (t130). After the opacity measurements, permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline), neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 0.89).
The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 108.29) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).
The test item was tested undiluted. Relative to the negative control, the test item caused an increase of the corneal opacity and permeability. The calculated mean IVIS was 64.55 (threshold for serious eye damage: IVIS > 55). According to OECD 437, the test item is classified as serious eye damaging.
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