Petrolatum (petroleum), oxidized, calcium salt

Endpoint summary

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.