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Diss Factsheets
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EC number: 947-968-9 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
- Test system:
- artificial membrane barrier model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: episkin
- Source strain:
- not specified
- Vehicle:
- physiological saline
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- Exposure times of 3, 60±5 and 240±5 minutes
- Number of replicates:
- 2
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- Exposure times of 3, 60±5 and 240±5 minutes
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 minutes
- Value:
- ca. 53
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The potential of the test item TERPENIC BASE to be corrosive to the skin was investigated through an in vitro skin corrosion study, using a commercial reconstructed human epidermis (RhE) model named EPISKIN™.
The blank, negative and positive controls gave acceptable results at all treatment times, thus the study was accepted as valid.
After 240 minutes of treatment, a reduction of mean percent viability to 34% of the concurrent negative control value was noted.
Based on this result, the test item TERPENIC BASE is identified as non-corrosive to the skin.
Reference
TwoMain Assays were performed.
In the firstMain Assay, the mean Optical Density of Blank Controls was 0.037, lower than the maximum acceptable value (0.1). All negative control mean OD values gave the expected baseline value and variability, in agreement with guideline indications. According to the method, each negative control mean value is considered the baseline value for the concurrent treatment series, thus they represent 100% of cell viability. Positive control results indicated an appropriate cell death with an acceptable relative cell viability (1% of the negative control value).
Based on the stated criteria, the experiment was accepted as valid.
The test item did not induce cell death in any replicate, after 3 or 60 minutes of treatment time. Marked reduction of mean percent viability was noted at 240 minute treatment time.
Each mean cell viability, after the concurrent blank subtraction, was as follows:
Treatment time (minutes) Mean cell viability (%)
3 113
60 140
240 34
Intra-replicate variability was acceptable with a difference of viability between the two replicates lower than 30%, for all treatment times.
Results obtained in this experiment using the longest treatment time (240 minutes) should be considered borderline, as viability values of the replicated tissues were one above and one below the threshold value. Moreover, test item features and results obtained for eyes corrosion are predictive of no corrosive potential for the skin. Based on these considerations, a Main Assay II was performed. In this second experiment, a slight reduction of mean percent viability was noted at all treatment times.
Each mean cell viability, after the concurrent blank subtraction, was as follows:
Treatment time (minutes) Mean cell viability (%)
3 61
60 80
240 53
Also in this experiment all the acceptability criteria were met with the exception that after 60 minutes of treatment intra-replicate variability slightly exceeded the maximum acceptable value (Δ%= 35.8). However, the results obtained with the replicate tissues were both predictive of no corrosive potential and thus were considered acceptable.
For each treatment time, the average of viability values obtained in the two experiments was calculated and results obtained were as follows:
Treatment time (minutes) Mean cell viability (%) - two experiments
3 87
60 110
240 44
Based on the results obtained, the test item TERPENIC BASE is identified as non-corrosive to the skin.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus (fresh bovine corneas)
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- > 3.88 - < 5.23
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- study cannot be used for classification
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
The OECD 437 study assay was performed obtaining a result of a calculated mean IVIS = 4.43.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made, so it has been classified as Eye Irrit. 2 (H319).
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