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Diss Factsheets
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EC number: - | 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
Not irritating to skin or eye.
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)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, 28 July 2015.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- “In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”. 06-Jul-2012.
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200-SIT)
- Version / remarks:
- 07-Nov-2014
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- The substance was stored at room temperature. The test substance appeared as a cream to tan solid. The expiration date of the test substance was 17 May 2020.
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test will be carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - Amount(s) applied (volume or weight with unit):
25 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 95 minutes (30 minutes in 37 degrees C, 60 minutes under sterile flow)
- Duration of post-treatment incubation (if applicable):
- 24 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 113.4
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was evaluated for skin irritation potential by assessing its effect on a reconstituted three-dimensional human epidermis model using MTT reduction as an indication of tissue viability. The test substance was observed to be non-irritating at doses up to 10 mg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- done in 1984 prior to 2008 and amending regulations
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984-10-02 to 1984-10-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Complete guideline conform study report available. Study is performed under GLP.
- Justification for type of information:
- The analogue approach is used for the hazard assessment of toxicological, eco-toxicological and environmental fate endpoints for the registration Pentamid™ KH (EC 934-047-1). The hypothesis is that data can be read-across between Pentamid™ KH and its structural analogues, based on structural similarity and common breakdown/metabolic products (Scenario 1 of the Read-Across Assessment Framework (RAAF, ECHA, 2015)).
For mammalian toxicity the “parent” substances show no significant systemic or dermal toxicity in mammals and vertebrates. One of the metabolic products of Pentamid™ KH, the well-studied terephthalic acid, has no significant systemic toxicity. The amine metabolite, however, shows diffuse mammalian systemic toxicity at moderate concentrations. This metabolite is employed in the risk assessment, in agreement with the European Union draft Risk Assessment Report of 2008.
The sole classification for Pentamid™ KH is the precautionary aquatic chronic 4 category, based on low water solubility and a log Kow higher than 4.
Read-across data, all evaluated as reliable according to Klimisch scores of 1 or 2, to estimate the toxicity of the registered substance is used for fulfilling the data requirements of the REACH registration and classifying potential hazards. This read-across approach is adequate for the purposes of risk assessment and classification and labeling. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- other: 0.9 % polyethyleneglycol
- Controls:
- not required
- Amount / concentration applied:
- 100 mg test substance moistened with 0.3 mL 0.9 % polyethyleneglycol
- Duration of treatment / exposure:
- 24 hours after application of the test substance into the conjuctival sac of the left eye, the eyes were washed out with lukewarm physiological saline.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Duration of post- treatment incubation (in vitro):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Draize method used for scoring of eye irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.1
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this guideline OECD 405 test and the results obtained, it is concluded that the source analogue substance is not irritating to the eyes. The target substance is not classified for eye irritation according to Regulation EC No. 1272/2008.
- Executive summary:
In order to assess the eye irritating potential of the test substance, 100 mg of
the source substance moistened with 0.3 mL of 0.9 % polyethyleneglycol was applied
into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye
served as control. After 24 hours the treated eye was washed. The assessment
of possible effects to the eyes was performed with the assistance of a lamp 60
minutes, 24, 48 and 72 hours after application of test item. The eye reactions
were assessed according to the numerical scoring system (acc. to Draize). The
description of the degree and nature of irritation and the presence of serious
damage were noted as follows:
- No mortality or signs of systemic toxicity occurred.
- Hyperemia was observed in all three animals at the one hour and 24 hour time
point with a maximum score of 2. This effect was still observed in one animal
with a score of 1 at the 48 hour time point (mean score 0.7 - 1 - 0.3). This effect
was reversible within 72 hours.
- Chemosis of the conjunctiva was observed in two animals one hour (maximal
score 2) and in one animal 24 hours after application (mean score 0 - 0.3 - 0).
This effect was reversible within 48 hours.
- No corneal opacity were observed in all three animals 24, 48 and 72 hours
after application of the test substance (mean score 0-0-0).
- No effects at Iris was observed in all animals 24, 48 and 72 hours after
application of the test substance (mean score 0-0-0).
Under the conditions of this test and the results obtained, it is concluded, that
the source test substance is not an irritant to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The substance was tested in an in vitro dermal irritation study (EpiDerm) and found to be non-irritating (not classified). A close structural analogue was tested in vivo in an OECD 405 compliant study, with a finding of not irritating. The criteria for classification according to Regulation EC No. 1272/2008 are not met.
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.
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