Registration Dossier

Administrative data

Description of key information

Acute Oral Toxicity:

Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils "sufficiently refined" and "insufficiently refined" is >5000 mg/kg.

Acute Dermal Toxicity:

Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils "sufficiently refined" is >5000 mg/kg and "insufficiently refined" is >2000 mg/kg.

Acute Inhalation Toxicity:

Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
5 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity:

Many key and supporting studies were available to assess the acute oral toxicity of other lubricant base oils (OLBO). Two studies were selected as key studies (API, 1982a and API, 1986a) and 14 were selected at supporting studies. The API 1982a study analyzed the acute oral toxic effects of a solvent dewaxed light paraffinic oil (CAS 64742-56-9), a sufficiently refined (IP 346 < 3%) OLBO. The API 1986a study analyzed the toxic effects of hydrotreated light naphthenic distillate (CAS 64742-53-6), an insufficiently refined (IP 346 3%) OLBO. In both studies, rats were administered a single neat oral dose (5 g/kg) via gavage of the respective OLBO. After 14 days of observation, no mortality or adverse clinical signs of toxicity were seen in either male of female rats. At necropsy, one female rat exhibited cystic masses on the spleen; otherwise, necropsy did not reveal any gross abnormalities in either male or female rats. The acute oral LD50 for both studies was >5,000 mg/kg (5 g/kg). Based on this data, solvent dewaxed light paraffinic oil and hydrotreated light naphthenic distillate are nontoxic when administered orally.

Supporting data from studies (API 1982b; 1982c; 1982d; 1982e; 1982f; 1982g 1986b; UBTL, 1983a; 1983b; 1983c; 1983d; 1983e; 1983f; 1983g; 1983h; 1983i; 1983j; 1983k; 1983l; and 1983m) conducted in rats demonstrate that other lubricant base oils (IP 346 < 3%) have acute LD50s >5000 mg/kg or >2000 mg/kg (NOTOX, 1994).

Acute Inhalation Toxicity:

Multiple key and supporting studies were available to assess the acute inhalation toxicity of other lubricant base oils. Two studies were selected as key studies (Exxon Biomedical Sciences, Inc., 1988a and API, 1987a) and 12 were selected as supporting studies. The API 1987a study analyzed the toxic inhalation effects of hydrotreated light naphthenic distillate (CAS 64742-53-6), an insufficiently refined (IP 346 ≥ 3%) OLBO. The Exxon Biomedical Sciences, Inc., 1988a study analyzed the toxic inhalation effects of a solvent extracted paraffinic oil, a sufficiently refined (IP 346 < 3%) OLBO.

 

In the Exxon Biomedical Sciences, Inc. 1988a study, five male and five female young adult Sprague- Dawley rats were exposed by inhalation route to MRD-87-102 (a sufficiently refined lubricant base oil; IP 346 <3%) for four hours (whole body) at a concentration of 5.53 mg/L. Animals then were observed for 14 days. No mortality in either the control or exposed group was reported. There were no statistically significant differences in mean body weight between groups. Based on the results of the study, the four hour LC50 for MRD-87-102 in rats by inhalation would appear to be greater than 5.53 mg/L.

In the API 1987a study, male and female rats were exposed to 5 mg/L aerosol (of API 83 -12, a hydrotreated light naphthenic oil) for 4 hours. Additional groups of rats were exposed to aerosol concentrations of 1, 1.5, 2.5, and 3.5 mg/L. Animals were observed for 14 days and necropsies were performed. No observations could be made in the 5 mg/L group because the aerosol was too dense. One rat/sex died at 1.0 mg/L and three rats/sex died at 2.5 mg/L while all animals (male and female) died when exposed to 3.5 mg/L and 5.0 mg/L. Based on these results, the LC50 is 2.18 mg/L (2180 mg/m3) for an "insufficiently refined" (IP 346 3%) OLBO. 

Numerous acute inhalation studies have been made on other lubricant base oils having viscosities ranging from 10-30 cSt (Exxon Biomedical Sciences Inc., 1988b; 1988c, Mobil Oil Corporation 1984a; 1984b, Bioresearch Laboratories, Ltd., 1983a; 1983b; 1983c; 1983d; 1984a; 1984b; 1984c; 1984c; 1984d; 1984e; 1984f; 1984g; 1984h, 1984i; 1984j; 1984k; and Whitman et al. 1989). The majority of the studies show no or minimal lethality at high doses (> 5 mg/L). Only one sample seems to be more toxic, API 83-12 (which results in LC50= 2.18 mg/L). This sample has higher aromatic content and slightly lower viscosity in comparison to the rest of the samples. Most likely the polycyclic aromatic compounds (PACs) content does not contribute to acute toxicity endpoints. Overall, the weight of evidence suggests that LC50values for this category of other lubricant base oils are greater than 5 mg/L.

Acute Dermal Toxicity:

Multiple studies were available to assess the acute dermal toxicity of other lubricant base oils. Two studies API, 1982a and API 1986a were selected as key studies and 7 were selected as supporting studies.

 

The API 1982a study analyzed the acute dermal toxic effects of solvent dewaxed light paraffinic oil (CAS 64742-56-9), a sufficiently refined (IP 346 < 3%) OLBO, at a dose of 5000 mg/kg bw/day for 24 hours on male and female rabbits. In this study, dermal administration at 5000 mg/kg did not result in any dermal irritation or signs of clinical toxicity. Gross necropsy did not reveal any signs of systemic toxicity at the 5000 mg/kg dose level.

The dermal LD50 was determined to be >5000 mg/kg bw.

Supporting data from studies (API 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; and 1986b) conducted in rabbits have also demonstrated that sufficiently refined other lubricant base oils (IP 346 < 3%) have dermal LD50s of >5000 mg/kg bw, >3000 mg/kg bw (IBTL, 1973), or >2000 mg/kg bw (UBTL 1984a; 1984b; 1984c; 1984d; 1984e; 1984f; and 1984g) .

 

The API 1986a study analyzed the acute dermal toxic effects of hydrotreated light naphthenic distillate (CAS 64742-53-6), an insufficiently refined (IP346 ≥ 3%) OLBO, at a dose of 2000 mg/kg bw/day for 24 hours on male and female rabbits. Neither substance caused mortality in the animals, and only slight skin irritation in the insufficiently refined OLBO-treated animals. The LD50 is greater than 2000 mg/kg bw/day.

Based on these results, sufficiently and insufficiently refined OLBOs are not acutely toxic when administered dermally.

Justification for selection of acute toxicity – oral endpoint

One of Twenty Three acute oral studies

Justification for selection of acute toxicity – inhalation endpoint

One of Twenty acute inhalation studies

Justification for selection of acute toxicity – dermal endpoint

One of Seventeen acute dermal studies

Justification for classification or non-classification

The sufficiently refined other lubricant base oils (IP 346 < 3%) are not required to be classified under the EU CLP Regulation (EC No. 1272/2008) and subsequent amendments thereof, since acute oral, dermal and inhalation toxicity data indicates that these oils have LD50s >2000 mg/kg or LC50s >5.53 mg/L.

The insufficiently refined other lubricant base oils (IP 346 3%) are also not required to be classified under the EU CLP Regulation (EC No. 1272/2008) and subsequent amendments thereof, since acute oral, dermal and inhalation toxicity data indicates that these oils have LD50s >2000 mg/kg or LC50s >5.0 mg/L.