Alcohols, C6-24 and C6-24-unsatd., distn. residues

Endpoint summary

Description of key information

An acute oral toxicity study according to OECD TG 423 (LD50 > 2000 mg/kg bw) as well as an acute dermal toxicity study according to OECD TG 402 (LD50 > 2000 mg/kg bw) are available. Additionally, company data from Henkel dated 1972 are available, which refer to an acute oral toxicity study with rats, having resulted in a LD0 value > 20000 mg/kg bw, and thus, in a LD50 > 20000 mg/kg bw. Furthermore, for alcohols, C6-24, distn. residues (CAS 102242-49-9), an oral and a dermal acute toxicity study are available, which are suitable for read across; because of structural and composition analogy, the results of both substances are similar.
Acute toxicity:
BASF Report 10A0276/12X160 from 2012: LD50 (oral) > 2000 mg/kg bw (LD50 (oral), cut-off = 5000 mg/kg bw)
Henkel company data from 1972: LD50 (oral) > 20000 mg/kg bw
BASF Report 11A0276/12X161 from 2012: LD50 (dermal) > 2000 mg/kg bw
Read across substance CAS 102242-49-9:
Cognis (now BASF) Report TBD880150: LD50 > 2000 mg/kg bw for acute oral toxicity
Cognis (now BASF) Report C0901283-5: LD50 > 2000 mg/kg bw for acute dermal toxicity  
No data are available for the acute inhalation toxicity.

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 adverse effect observed

Additional information

Acute oral toxicity:

The acute oral toxicity of “alcohols, C6 -C24 and C6 -C24 unsat., distn residues” was evaluated in a study performed according to OECD guideline 423 under GLP conditions (BASF 10A0276/12X160, 2012). Two groups of three female Wistar rats were consecutively treated with the undiluted test substance (85.1% pure) via gavage at the limit dose of 2000 mg/kg bw.

No mortality occurred and no clinical signs of toxicity were reported during the 14-days observation period. The body weights were as expected throughout the study and no macroscopic findings were detected during necropsy. Thus, the oral LD50 was > 2000 mg/kg bw corresponding to a LD50 cut-off value of 5000 mg/kg bw according to Annex 2d of the guideline.

Moreover, company data from Henkel dated 1972 are available, which refer to an acute oral toxicity study with rats, having resulted in a LD0 value > 20000 mg/kg bw, and thus, in a LD50 > 20000 mg/kg bw. The acute oral toxicity of the read across substance "alcohols C6 -24, distn. residues" (CAS 102242-49-9) was investigated in a limit test study at a dose level of 2000 mg/kg bw (Cognis TBD880150, 1988). The test material was administered by single gavage to each of 5 female and 5 male Wister rats. Neither mortality nor clinical signs were observed over a 14 -day observation period, and the body weight increased normally. Thus, the LD50 was > 2000 mg/kg bw.

Acute dermal toxicity:

The acute dermal toxicity of “alcohols, C6-C24 and C6-C24 unsat., distn residues” was evaluated in a study performed according to OECD guideline 402 under GLP conditions (BASF 11A0276/12X161, 2012). Five Wistar rats per sex were dermally treated with the undiluted test substance (85.1% pure) under semi-occlusive conditions at a limit dose of 2000 mg/kg bw. The test substance was applied at the previously clipped dorsal and dorso-lateral parts of the trunk. After 24 hours, test substance residues were washed-off with warm water.

No mortality occurred and no clinical signs of toxicity were reported during the 14-days observation period. The body weights were as expected throughout the study (except for one male and one female with body weight stagnation but not reduction) and no macroscopic findings were detected during necropsy. Thus, the dermal LD50 was > 2000 mg/kg bw.

Supporting information is given by the results of an acute dermal toxicity of the read across substance "alcohols C6-24, distn. residues" (CAS 102242-49-9) that was investigated in a OECD 402 study (Cognis C0901283 -5, 2010). The limit test with 2000 mg/kg bw was performed with 5 male and 5 female Wistar rats. The rats were exposed for 24 hours to the unchanged test material under occlusive conditions. Up to 6 hours after application, the rats appeared apathic. From day 1 to day 14 no mortality or clinical signs were observed. The body weight developed normally and no pathological abnormalities were found at the end of the study. Thus, the LD50 was > 2000 mg/kg bw.

Acute inhalation toxicity:

Fatty alcohols are not very volatile and thus, exposure of human via the inhalation route to "alcohols, C6-C24 and C6-C24 unsat., distn residues" is considered to be unlikely, therefore testing for acute inhalation toxicity appears unnecessary.In addition, a spray application is not forseen.

Justification for classification or non-classification

Based on the available data including read across from a close homologue substance, "alcohols, C6 -C24 and C6 -C24 unsat., distn residues" is expected to be practically non-toxic via the oral and the dermal route of exposure. Thus, there is no need for classification according to the EU Directive 67/548/EEC and to the CLP Regulation (EC) No.1272/2008.