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Diss Factsheets
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EC number: 202-491-9 | CAS number: 96-23-1
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- other: In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Study period:
- The assessment was conducted in May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8).
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- n accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behaviour has been
conducted to the extent that can be derived from the relevant available information.The assessment
is based on the Guidance on information requirements and chemical safety assessment R.7c:
Endpoint specific guidance (ECHA, November 2014) - GLP compliance:
- no
- Remarks:
- No relevant for assessment
- Radiolabelling:
- no
- Metabolites identified:
- yes
- Details on metabolites:
- In rats, oral administration of 1,3-DCP (50 mg/kg [0.39 mmol/kg] bw) daily for 5 days resulted
in the detection of β-chlorolactate (~5% of the dose), N,N'-bis(acetyl)-S,S'-(1,3bis(cysteinyl))propan-2-ol
(1%), and N-acetyl-S-(2,3-dihydroxypropyl)cysteine in the urine. The epoxide epichlorohydrin was proposed as an intermediate,
which can then conjugate with glutathione (GSH), forming mercapturic acid derivatives.
The metabolic conversion of 2chloropropane-1,3-diol to N-acetyl-S-(2,3-dihydroxypropyl)cysteine
confirmed that an epoxide intermediate was involved. Additionally, epichlorohydrin may
hydrolyze to 3-MCPD, which can undergo further metabolism to produce β-chlorolactate (Jones and Fakhouri, 1979)
In another rat study, a single subcutaneous (s.c.) injection of 1,3-DCP (~68 mg/kg [0.53
mmol/kg] bw) resulted in ethyl acetate-extractable metabolites in the 24-hour urine—
1,2-propanediol (0.43% of the dose) and 3-MCPD (0.35%). The parent compound comprised
2.4% (Koga et al., 1992).
Jones, A.R., and Fakhouri, G. 1979. Xenobiotica 9(10):595-599.
Koga, M., Inoue, N., Imazu, K. Yamada, N., and Shinoki, Y. 1992. J. Univ. Occup.
Environ. Health Jpn. 14:13-22. - Conclusions:
- The available information demonstrates that absorption of substance from the gastrointestinal tract following oral ingestion occurs given the test items physico-chemical characteristics.
These characteristics together with the observed dermal toxicity and corrosive properties of 1,3-dichloropropan-2-ol also indicate absorption via dermal exposure of test item occurs. Absorption via the inhalation route occurs and results in widespread systemic distribution of the substance resulting in significant toxicological lesions. It is known that 1,3-dicholoropropan-2-ol undergoes hepatic transformation and subsequent renal clearance.
Reference
TOXICOKINETIC BEHAVIOUR
1,3 -dichloropropan-2 -ol is a relatively non-volatile liquid with a vapour pressure of 150 Pa at 20 celsius, however the supporting toxicological information from occupational accident reports show that inadvertent inhalation or dermal exposure in confined spaces is likely to lead to an elevation in systemic toxicity. 1,3 -dichloropropan-2 -ol was identified to be a skin and eye corrosive substance based upon the effects to in vitro organotypic models.
These results in conjunction with the result from the acute dermal toxicty study and the molecular weight and log Pow indicate that absorption occurs via the dermis. Acute oral toxicity results showed the LD50 to be @100 mg/kg body weight, based upon the molecular weight and log Pow, significant absorption form the Gastrointestinal tract can be anticipated.
Absorption
The general physico-chemical properties of 1,3 -dichloropropan-2 -ol including the molecular
weight and log Pow would indicate that significant absorption is possible by oral , dermal and inhalation exposure
Distribution
Information relating to the distribution of 1,3 -dichloropropan-2 -ol is limited; however, the chemical
characteristics and findings from the inhalation Repeated Dose Toxicity and drinking water carcinogenicity Study implies
widespread systemic distribution occurs following oral administration/ gastric absorption or inhalation exposure.
Metabolism
The negative findings in systemic genotoxicity assays in vivo indicate that reactive
genotoxic metabolites, if formed, must be too transient for 1,3-DCP to be genotoxic in vivo or
that the target tissues and/or endpoints evaluated are not relevant to 1,3-DCP-induced
genotoxicity. The observation of a positive COMET assay in the glandular stomach of treated mice adds further evidence to this proposition.
In rats treated with 1,3-DCP, the significantly increased hepatic malondialdehyde level was associated with decreases of liver GSH S-transferase activity and GSH content. Lipid peroxidation was suggested as a causative mechanism of the hepatotoxicity [diffuse massive
necrosis] (Katoh et al., 1998; Kuroda et al., 2002). Inhibition of CYP2E1 lowered the hepatotoxicity in the animals (Stott et al., 1997).
Excretion
The substance is known to undergo hepatic metabolism with glutathione conjugation and hydrolysis; toxic effects are also noted in the kidneys in the repeat dose inhaltion study and 2 year carcinogenicity study . Consequently the main route of excretion for 1,3 -dichloropropan-2 -ol and its metabolites is through the urinary tract.
Katoh, T., Haratake, J., Nakano, S., Kikuchi, M., Yoshikawa, M., and Arashidani, K. 1998. Ind. Health 36:318-323.
Kuroda, Y., Fueta, Y., Kohshi, K., Nakao, H., Imai, H., and Katoh, T. 2002. J. UOEH 24(3):271-280.
Stott, I., Murthy, A., Robinson, A., Thomas, N.W., and Fry, J.R. 1997. Hum. Exp. Toxicol. 16(5): 262-266.
Description of key information
The available information demonstrates that absorption of substance from the gastrointestinal tract following oral ingestion occurs given the test items physico-chemical characteristics.
These characteristics together with the observed dermal toxicity and corrosive properties of 1,3-dichloropropan-2-ol also indicate absorption via dermal exposure of test item occurs. Absorption via the inhalation route occurs and results in widespread systemic distribution of the substance resulting in significant toxicological lesions. It is known that 1,3-dicholoropropan-2-ol undergoes hepatic transformation and subsequent renal clearance.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
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.