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EC number: 270-348-8 | CAS number: 68425-34-3
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The acute toxicity of petrolatum is low with no observed mortalities from oral or dermal applications.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Sufficiently refined petrolatums have low acute toxicity with an oral LD50 greater than 5000 mg/kg (in rat) and a dermal LD50 of greater than 2000 mg/kg (in rabbit).
Sufficiently Refined Petrolatum
No acute oral or dermal toxicity studies have been reported for sufficiently refined petrolatum, but data have been reported for other lubricant base oils (IP 346 <3%) and paraffin and hydrocarbon waxes, materials similar to sufficiently refined petrolatum.
Acute Oral Toxicity:
One key read-across study (API 1982) was identified to evaluate the acute oral toxicity potential of sufficiently refined petrolatum. In this study, paraffinic oil sample API 78-9 (Other lubricant base oil, IP 346 <3%; CAS No. 64742-56-9) was administered via oral gavage to 5 Sprague-Dawley rats per sex at a single dose of 5,000 mg/kg (5 g/kg). The rats were observed for clinical signs of toxicity, changes in body weight, and other gross abnormalities over a 14-day post-exposure observation period. All rats were killed and necropsied on day 14. No mortalities or any sign of clinical sign of toxicity were observed in either male or female rats dosed at 5,000 mg/kg. Body weight gain was observed to be normal in all animals. One animal did exhibit hydronephrosis in the right kidney but this was not considered to be treatment-related. Necroscopy did not reveal any gross abnormalities in either male or female rats. Acute oral LD50>5,000 mg/kg (5 g/kg). Paraffinic oil 78-9 was observed to be practically non-toxic when administered orally via gavage to Sprague-Dawley rats.
Supporting studies conducted in rats (IBR, 1976) with paraffin and hydrocarbon waxes and IUCLID4 data (IBR, 1976; Lawall and Harrison Research Laboratories, 1969) also indicate that the acute oral LD50 is >5000 mg/kg.
Acute Dermal Toxicity:
One key read-across study (BIBRA, 1993a) was identified to evaluate the acute dermal toxicity potential of sufficiently refined petrolatum. In this study, groups of five male and five female young adult Sprague-Dawley rats were dermally exposed to paraffin wax (SX30) for 24 hours to approximately 10% of body surface at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days. The test article caused slight skin irritation reactions in a majority of treated animals which persisted throughout the study. However, a previous study performed at BIBRA (Report No.1091(3) /1/93) demonstrated that SX30 is only a mild irritant and has no corrosive (irreversible) properties when applied to intact rabbit skin for 4 hours. Based on the absence of mortality, minimal clinical observations, standard body weight and weight gain, and necropsy results, the dermal LD50 was determined to be > 2000 mg/kg body weight.
Supporting studies conducted in rabbits (CTFA, 1972a; Elder, 1984) with a 50% solution of paraffin wax in petrolatum at a dose of 3600 mg/kg (closed-patch exposure for 24 hours) did not indicate any systemic effects or abnormalities. The acute dermal LD50 was therefore determined to be >3600 mg/kg.
Inhalation toxicity studies were not reported for sufficiently refined petrolatum since inhalation is not an expected route of exposure due to the very low vapour pressure of these substances.
Justification for classification or non-classification
Sufficiently refined petrolatums do not meet the EU CLP (EC No. 1272/2008) criteria for acute oral, dermal, or inhalation toxicity and are not classified.
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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