Reaction mass of Alcohols, C20-24 (even), Slack wax (petroleum), Petrolatum (petroleum); oxidized, compounds with 2-(methylamino)ethanol

Endpoint summary

Description of key information

Oral route: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw (OECD 420 and EU Method B.1 bis).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral route

The key study was performed to assess acute oral toxicity of the test item in the Wistar strain rat in compliance with the OECD Guideline for Testing of Chemicals No 420 “Acute Oral Toxicity – Fixed Dose Method” (2001) and Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No 440/2008.

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a suspension in distilled water, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

 

No unscheduled animal deaths took place during the study and there were no signs of systemic toxicity. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw.

Dermal route

Repeated exposure of the skin is not expected under normal condition of use and experimental data shows that the substance is a low melting point solid that is non-toxic via the oral route under acute conditions (LD50 > 2000 mg/kg). In addition, the test material has been determined to have a low vapour pressure (0.449 Pa at 25 °C) and high onset boiling point range (decomposition from approximately 195 °C at 100 kPa). These data indicate that the potential for dermal absorption after exposure to vapour is low. Furthermore, the substance is a UVCB with a relatively high molecular weight, is poorly soluble in water (5.86 x 10E-02 g/L by total organic carbon at 20.0 ± 0.5 °C) and has a Log10 Kow value range of > 10.0. Consequently, and in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance (Version 2.0; November 2014), the substance is considered insufficiently soluble to partition from the stratum corneum into the epidermis and the majority of UVCB constituents are likely to be too large to favour dermal absorption (molecular weight > 100 g/moL and log10 Pow > 4). Investigation of acute toxicity via the dermal route is therefore contraindicated.

Inhalation route

 

The substance decomposes from approximately 195 °C at 100 kPa and the vapour pressure has been determined to be 0.449 Pa at 25 °C. It is therefore expected that inhalation exposure will be low under general use conditions at ambient conditions. Lack of systemic toxicity when the substance is administered via the oral route suggests that determined vapour pressures of 13.2 Pa at 60°C and 7.59 at 66°C also give no cause for concern. The inhalation route is therefore not the most applicable method of investigating acute toxicity.

Justification for classification or non-classification

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was considered to be > 2000 mg/kg body weight and, in accordance with Regulation (EC) No. 1272/2008, classification for acute oral toxicity is not required.