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EC number: 201-327-3 | CAS number: 81-13-0
- 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
The acute oral LD50 was determined to be > 10000 mg/kg bw. The acute dermal LD50 was determined to be > 2000 mg/kg bw. No signs of inhalation toxicity could be detected during a 7 h inhalation study with an atmosphere saturated with the test item.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given, equivalent or similar to OECD guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- BASF-Test.
In principle, the methods described in OCED guideline 401 were used. - GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
male and female rats
- Age at study initiation: young adult, no further data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
distilled water
- Concentration in vehicle: 46.4 - 50% (w/v)
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- up to 10000 mg/kg bw; no further details
- No. of animals per sex per dose:
- 5-10/sex/group; no further data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: before the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: In the highest dose group (10000 mg/kg bw), impaired general state with unspecific symptoms was noted at the first day of the study. No other findings were observed.
- Gross pathology:
- No pathological findings were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item revealed an acute oral LD50 greater than 10000 mg/kg bw in rats.
- Executive summary:
The LD50 was > 10000 mg/kg bw.
Groups of male and female rats were administered the test substance by gavage as an aqueous solution at doses of up to 10000 mg/kg bw and were observed for 14 days. No deaths were observed. Clinical signs of toxicity were limited to impaired general state with unspecific symptoms observed at the highest dose level at the day after dosing only. Pathology revealed no abnormal findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Basic data are given, equivalent or similar to OECD guideline.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given. Equivalent or similar to OECD guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The study was carried out in accordance with Smyth HF et al (1962). Am Ind Hyg Ass J 23: 95-107.
In principle, the methods described in OCED guideline 403 were used. - GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- other: Inhalation Risk Test
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
male and female rats
- Age at study initiation: young adult, no further data - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 7 h
- Concentrations:
- atmosphere saturated with vapours of the test substance, no further data
- No. of animals per sex per dose:
- totally 6 males and 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: before the start of the study and at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LC50
- Based on:
- test mat.
- Exp. duration:
- 7 h
- Remarks on result:
- other: No death were observed during a 7 h-inhalation period of the test animals in a saturated atmosphere at room temperature. As the saturation vapour pressure is very low (less than 0.001 Pa at 20 °C), no exact concentration estimation could be performed..
- Mortality:
- No mortality was observed when 12 rats were exposed for 7 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.
- Clinical signs:
- other: No clinical signs of toxicity were observed.
- Body weight:
- no data
- Gross pathology:
- No abnormal findings were reported.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No death were observed during a 7 h-inhalation exposure of rats to a saturated atmosphere of the test item at room temperature.
- Executive summary:
In an acute inhalation toxicity study, one group of 12 rats (6/sex) was exposed for 7 h to a saturated atmosphere of D-Panthenol at 20°C. Animals then were observed for 14 days. No mortality occurred. No clinical signs of toxicity. were observed. No gross pathological findings were reported.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Basic data are given. Equivalent or similar to OECD guideline.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1994-08-11 to 1994-08-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. For justification of read across please refer to the attachment in IUCLID5 section 13.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- directive 92/69/EEC
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 207 g (mean; females: 175 g (mean)
- Fasting period before study: no
- Housing: individually in polycarbonate cages
- Diet: Kliba 343 rodent diet from Klingentalmühle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: mean 21 °C
- Humidity: 50 % relative Humidity
- Air changes: approx. 15 air changes per hr
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test substance was applied to an area of approximately 25 cm² (5x5 cm) for males and 18 cm² (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.), with drops of petrolatum.
- Duration of exposure:
- 24 hours
- Doses:
- single dose: 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Shaving: One day before exposure (day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
- Application: The test substance was applied to an area of approximately 25 cm² (5x5 cm) for males and 18 cm² (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.), with drops of petrolatum.
- Frequency: Once, on day 1.
- Dose level/volume: 2000 mg/kg (1.869 mL/kg) body weight. Dose volume calculated as follows: dose level : specific gravity
- Application period: 24 hours, thereafter dressings were removed and residual test substance removed using a tissue moistened with tap water. - Statistics:
- NA
- Preliminary study:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of ill health or behavioural changes were observed during the study period. Abnormalites in the treated skin area included scabs in one male between days 5 and 9.
- Gross pathology:
- Macroscopic post mortem examination of the animals at termination revealed a yellowish hard nodule in the papillary process of the liver in one female and pelvic dilation of the kidney in one male. These findings are incidentally noted among the animals of this age and strain and are considered not related to treatment with the test substance.
- Other findings:
- Macroscopic post mortem examination of the animals at termination revealed a yellowish hard nodule in the papillary process of the liver in one female and pelvic dilation of the kidney in one male. These findings are incidentally noted among the animals of this age and strain and are considered not related to treatment with the test substance.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- rat: LD50 > 2000 mg/kg bw.
- Executive summary:
Based on results obtained from read across substance the dermal LD50 value for D-Panthenol was determined to be > 2000 mg/kg bw.
The dermal LD50 value of the test item was determined in rats in a study according to OECD guideline 402 / EU method B.3. Five male and five female Wistar rats were exposed to a dose of 2000 mg/kg bw of the test item in a semi-occlusive exposure for a duration of 24 hours. The remaining test material was washed off with water, and the animals were observed for clinical signs for 14 days. No mortality occurred during the study period. No clinical signs of ill health or behavioural changes were observed during the study period. Abnormalities in the treated skin area included scabs in one male between days 5 and 9. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. However, three females showed low body weight gain over the second week of the study. Macroscopic post mortem examination of the animals at termination revealed a yellowish hard nodule in the papillary process of the liver in one female and pelvic dilation of the kidney in one male. These findings are incidentally noted among the animals of this age and strain and are considered not related to treatment with the test substance. The dermal LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight.
Reference
no remarks
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP-Guideline study.
Additional information
Acute toxicity: oral
The LD50 was > 10000 mg/kg bw. Groups of male and female rats were administered the test substance by gavage as an aqueous solution at doses of up to 10000 mg/kg bw and were observed for 14 days. No deaths were observed. Clinical signs of toxicity were limited to impaired general state with unspecific symptoms observed at the highest dose level at the day after dosing only. Pathology revealed no abnormal findings.
Acute toxicity: inhalation
No mortality was observed when 12 rats were exposed for 7 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound. No clinical signs of toxicity and no gross pathological findings were reported.
Acute toxicity: dermal
Based on results obtained from read across on data in section 7.2.3 the dermal LD50 value for D-Panthenol was determined to be > 2000 mg/kg bw. The close structural similarity between the read-across substance and Panthenol strongly suggest that the LD50 for D-Panthenol is also > 2,000 mg/kg bw. For justification of read across please refer to the attachment in IUCLID5 section 13. Based on experience obtained from wide spread human use of the substance as pharmaceutical salve, no acute dermal toxicity is expected. Further, information on acute oral and inhalation toxicty is available. No acute oral toxicity was observed up to the limit dose. Furthermore, no acute inhalation toxicty was observed up to the maximal achievable concentration of test item in air. The substance is practically non-toxic after acute exposure and thus, no further information can be expected from acute dermal toxicty testing. Based on the available information acute dermal toxicity can be excluded and further testing would not be in line with animal welfare.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – inhalation endpoint
Only one study available. No death were observed during a 7 h-inhalation exposure of rats to a saturated atmosphere of the test item at room temperature.
Justification for selection of acute toxicity – dermal endpoint
The close structural similarity between DL-Ethyl Panthenol and Panthenol strongly suggest that the LD50 for D-Panthenol is also > 2,000 mg/kg bw. For justification of read across please refer to the attachment in IUCLID5 section 13.
Justification for classification or non-classification
Based on the results obtained from testing the substance was not classified and labeled according to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD).
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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