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EC number: 203-471-2 | CAS number: 107-19-7
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed prior to OECD Guidelines and GLP. However, study performance was similar to OECD Guideline 411 with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The study was performed prior to existing OECD Guidelines, but can be regarded as equivalent or similar to OECD GL 411 with certain limitations.
- less than 20 animals were tested per dose group
- intact skin and abraded skin were exposed to test item
- no ophtamological examination was performed
- not all organs listed in OECD 411 were examined histopathologically - GLP compliance:
- no
- Remarks:
- test predated GLP
- Limit test:
- no
Test material
- Reference substance name:
- Prop-2-yn-1-ol
- EC Number:
- 203-471-2
- EC Name:
- Prop-2-yn-1-ol
- Cas Number:
- 107-19-7
- Molecular formula:
- C3H4O
- IUPAC Name:
- prop-2-yn-1-ol
- Details on test material:
- Test substance: Propargyl Alcohol 11-72063 - B.#155
Vehicle: distilled water
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no information
- Age at study initiation: no information
- Weight at study initiation: 2 - 3 kg
- Fasting period before study: no information
- Housing: no information
- Diet (e.g. ad libitum): no information
- Water (e.g. ad libitum): no information
- Acclimation period: two weeks
ENVIRONMENTAL CONDITIONS
no information
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Details on exposure:
- Route of Administration: dermal
Thirty-six albino rabbits in the weight range af 2-3 kg were set aside and observed for a period af two weeks to assure normality. The animals were then divided into four groups.
The test material was applled as w/v solutions in distiled water using 0%, 1. 0%, 0.3% and 0. 1% for controls, groups II , III and IV, respectively. Beginning on the 63rd day the daily dosage applied to group II was doubled, using a 2.0% solution. All dosages were applied In four equal increments, equally spaced through the day, five days per week. All animais were confined throughout each 8-hour exposure day. Control animals were handled in a manner similar to the test animais, applications of distilled water being made four times daily. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 3 or 10 (20 beginning on day 63) mg/kg bw/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 4 - 5 rabbits/sex/dose and control group:
Group I (control): Males Intact skin 3, Abraded skin 2; Females Intact skin 2, Abraded skin 3; (n = 10),
Group II (10* mg/kg/day): Males Intact skin 3, Abraded skin 2; Females Intact skin 2, Abraded skin 3; (n = 10) (20* applied, starting on day 63),
Group III (3 mg/kg/day): Males Intact skin 2, Abraded skin 2; Females Intact skin 2, Abraded skin 2; (n = 8),
Group IV (1 mg/kg/day): Males Intact skin 2, Abraded skin 2; Females Intact skin 2, Abraded skin 2; (n = 8). - Control animals:
- yes, concurrent vehicle
- Details on study design:
- All animals were weighed twice weekly during the first four weeks of the study and weekly thereafter, doses being adjusted. Hematology (hemoglobin, red blood cell count, white blood cell count, differential count) was performed prior to the experiment, at 45-days and at termination. Determination of alkaline phosphatase, blood urea nitrogen (BUN) and serum glutamlc pyruvic transaminase (SGPT) were performed prior to the start of the experiment, at 14-days and at 80-days. All rabbits were sacriflced for autopsy at terminatlon except for two rabblts (one control and one from Group II) sacrlficed at 28-days and two rabblts (one control and one from Group II) sacrificed at 56-days. Major organs of all animais were removed, weighed and tissues from the control and Group II animals were examined microscoplcally.
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- see "details on study design"
- Sacrifice and pathology:
- see "details on study design"
- Statistics:
- no data
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No lethality occurred. No local effects were found. Other clinical signs were not reported.
BODY WEIGHT AND WEIGHT GAIN:
Analysis of the weight changes shows that there were no patterns of response attributable to the dosages applled. Neither the sex of the animals nor the condition of the skin at application (abraded or intact) appears to have any significant effect upon the experimental animals' weight changes as compared to those of the control animals.
FOOD CONSUMPTION: No information.
FOOD EFFICIENCY: No information.
WATER CONSUMPTION: No information.
OPHTHALMOSCOPIC EXAMINATION : Not performed.
HAEMATOLOGY:
Hematological findings in the experimental animais did not differ significantly from those of the control animais. All were within the normal limlts for the species.
CLINICAL CHEMISTRY (Blood chemistry):
Analysis of the values obtained for alkaline phosphatase, BUN (blood urea nitrogen), and SGPT (serum glutamic pyruvic transaminase) shows that there was no significant difference between any of the experimental groups as compared to the control group.
URINALYSIS: Not performed.
NEUROBEHAVIOUR: Not performed
ORGAN WEIGHTS / GROSS PATHOLOGY / HISTOPATHOLOGY::
No noteworthy observations were made upon gross examination of the animais at autopsy. Results of the microscopic examinatlon of the organs of the animals revealed no signiflcant differences between tissues from control and treated rabbits. All changes found were due to spontaneous disease or to the mechanical techniques of the study.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 - <= 20 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- no systemic effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Appllcation of Propargyl Alcohol 11-72063 - B. #155 to the intact or abraded skin of young adult rabblts in daily doses of up to 10 mg/kg over a 63-day period and up to 20 mg/kg over a 28-day perlod produced no systemic effects. At the dosages tested, Propargyl Alcohol 11-72063 - B.#155 does not constltute a systemic hazard by skin absorption in rabbits.
Applicant's summary and conclusion
- Executive summary:
In a repeat-dose dermal toxicity study, Propargyl alcohol was applied as aqueous solution (0.1, 0.3 and 1-percent Propargyl alcohol in distilled water) to the intact and abraded skin of 2 - 3 male and female albino rabbits at dose levels of 0, 1, 3 and 10 mg/kg bw/day, 8 hours/day for 5 days/week during a 91-day period, beginning on day 63, the top dose was increased to 20 mg/kg bw/day.
Body weight gain changes and biochemical and hematological parameters did not differ significantly from those of the control group. No substance-related gross or microscopic tissue changes were observed. Application of Propargyl alcohol to the intact or abraded skin in daily doses of 1 or 3 mg/kg bw/day over a 90-day period, or 10 mg/kg bw/day for day 1-62 and subsequently 20 mg/kg bw/day for day 63-90 produced no systemic effects (including body weight gain, haematology, and histology). Furthermore, no local effects were seen.
The NOAEL derived from this study is 10 – 20 mg/kg bw/day.
This dermal toxicity study in the rabbit is acceptable and satisfies in general the guideline requirement for a repeat-dose dermal toxicity study (OECD GL 411) with some restrictions due to the fact that the study was performed prior to the existing guideline.
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