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EC number: 701-299-7 | CAS number: -
The substance 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (NAF-AO) [EC no. 701-299-7] (see Chap. 1) shows low oral, dermal, and inhalation acute toxicity. Discriminating doses (oral studies) were determined to be 2000 mg/kg bw (no mortality observed). Application of the substance as aerosol at a concentration of 5.14 mg/L did not result in any mortality (LC50 > 5000 mg/m³). The LD50 obtained in an acute dermal toxicity study was > 2000 mg/kg bw. Combined results indicate that NAF-AO is of low acute toxicity independent of the application route.
In this study, the test substance was given to 10 animals at a concentration of 16 mL/kg bw. Out of the 10 animals, 3 died as a result of the treatment. The 14 day observation period revealed that there were some signs of toxicity in the test group. However as the dose is 8 times the OECD recommend limit dose, this is to be expected. As such, no futher testing would be required.
The particle size analysis of the atmosphere drawn from the animals’ breathing zone, was as follows
[see Report Appendices 1 and 2]:
Mean Achieved AtmosphereConcentration ± SD (n = 17) [mg/L]
Mean Mass MedianAerodynamic Diameter (n = 3) [µm]
Geometric Standard Deviation[mm]
Inhalable Fraction[wt% < 4 µm]
5.14 ± 0.64
Table No. 1: Individual body weight of animals – 2000 mg/kg – males
Body weight gain (g)
day 0-8 dayp.a.
Table No. 2: Individual body weight of animals – 2000 mg/kg – females
The test substance, Novares TL 10, applied on skin at a dose 2000 mg/kg of animal weight did not cause death of animals.
Clinical signs of intoxication (piloerection, decreased response to stimuli) were observed in all males and four females. Transient decreases in body weight of females were recorded during study. No macroscopic changes were diagnosed during pathological examination of the animals.
The substance NAF-AO is produced under variable conditions resulting in different technical products of the substance. Several of these products have been tested for acute toxicity.
Acute oral toxicity
Two GLP compliant studies according to OECD TG 423 (acute toxic class method) have been conducted on the acute oral toxicity endpoint using two technical products of NAF-AO (Novares L 100 and L 800). No mortality was observed in either study. The discriminating dose was determined to be > 2000 mg/kg bw (LD0 = 2000 mg/kg bw).
In an early pre-guideline, pre-GLP study, the former technical product of NAF-AO (product 161001, Cumaron-Inden Harz B1 flüssig) was examined in an acute oral toxicity study similar to OECD TG 401 carried out as limit test. At a test concentration of 16 mL/kg bw, a mortality of 3 out of 10 animals (30 %) was observed. The test concentration corresponds to a dose of ca. 14,000 to 16,000 mg/kg bw. The LD50 was determined to be > 16 mL/kg bw. With this concentration, the limit value of OECD test guidelines (2000 mg/kg bw) is exceeded 7 to 8 fold.
The overwhelming weight of evidence suggests that the substance NAF-AO is not likely to be acutely toxic via the oral route.
Acute dermal toxicity
A GLP compliant study (OECD 402) has been conducted on the acute dermal toxicity endpoint using NAF-AO in form of its technical product Novares TL 10.
No deaths were recorded. As such it can be concluded that the hydrocarbon mixture has a low acute dermal toxic potential. The LD50 in the study was greater than 2000 mg/kg bw, and no significant treatment related toxicities were seen.
Acute inhalation toxicity
A GLP compliant study was conducted using NAF-AO (technical product Novares TL 10) as an aerosol via the inhalation route. More than 70% of the aerosol was respirable (MMAD < 4 µm). No animal deaths were observed during the study. The LC50 was greater than 5.14 mg/L. No significant toxicity was noted.
Overall, the acute toxicity of the substance NAF-AO in its different forms is very low. No mortality was observed in limit tests according to OECD TG for the oral, the dermal, and the inhalation route. Only at a very high oral dose in an old pre-GLP, pre-guideline test in the range of 15,000 mg/kg bw, 30% mortality was observed. Limit values are exceeded manifold in this test. This low percentage of dead animals confirms the low acute toxicity of the substance NAF-AO.
Since both, acute oral and dermal toxicity values are greater than 2000 mg/kg bw and the acute inhalation toxicity value is above 5 mg/L, classification according to Regulation (EC) No 1272/2008 (CLP regulation) is not required.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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