Alcohols, C16-18, ethoxylated, phosphates

Endpoint summary

Description of key information

Oral LD50 (OECD guideline 401), rat > 10000 mg/kg bw
Dermal LD50 (OECD guideline 402), rat > 2000 mg/kg bw
Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from a reference substance with similar structure and intrinsic properties. Read-across is justified based on breakdown products and similarities in PC/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

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

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from a reference substance with similar structure and intrinsic properties. Read-across is justified based on breakdown products and similarities in PC/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

Justification for grouping of substances and read-across

There are no data available for the acute toxicity of Alcohols, C16-18, ethoxylated, phosphates (CAS 106233-09-4). In order to fulfil the standard information requirements set out in Annex VIII in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity,Alcohols C16-18 (even numbered), ethoxylated (< 2.5 EO)(CAS 68439-49-6) and Alcohols C10-16, ethoxylated (< 2.5 EO)(CAS 68002-97-1) are selected as source substances for assessment of acute toxicity.

Acute toxicity

	Target substance	Source substance	Source substance
CAS	106233-09-4 (a)	68439-49-6 (b)	68002-97-1 (b)
Chemical name	Alcohols, C16-18, ethoxylated, phosphates	Alcohols C16-18 (even numbered), ethoxylated (< 2.5 EO)	Alcohols C10-16, ethoxylated (< 2.5 EO)
MW	322.42 – 867.27 g/mol	242.5 – 402.7 g/mol	158.3 – 346.6 g/mol
Acute toxicity, oral	RA:68439-49-6	Experimental result:LD50 > 10,000 mg/kg bw	--
Acute toxicity, dermal	RA:68002-97-1	--	Experimental result:LD50 > 2000 mg/kg bw

(a) The substance subject to the REACh Phase-in registration deadline of 31 May 2013 is indicated in bold font. Only for this substance a full set of experimental results and/or read-across is given.

(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

The read-across is mainly based on similar precursers/breakdown products of the target and the source substances. The available endpoint information is used to predict the same endpoint forAlcohols, C16-18, ethoxylated, phosphates(CAS 106233-09-4).

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Discussion

An acute oral toxicitystudy conducted withAlcohols C16-18 (even numbered), ethoxylated (< 2.5 EO) (CAS 68439-49-6)was performed according to OECD Guideline 401 with 5 Wistar rats per sex (Mürmann, 1986). The animals received a single dose of 10,000 mg/kg bw test substance via gavage. No mortality occurred. The only clinical sign of toxicity observed was piloerection. No effects on body weight and upon necropsy were observed. The LD50 is greater than 10,000 mg/kg bw.

An acute dermal toxicity study with Alcohols C10-16, ethoxylated (< 2.5 EO) (CAS 68002-97-1) was conducted similar to OECD Guideline 402 (Thompson, 1982). The test substance was applied at a dose of 2000 mg/kg bw to the abraded skin of New Zealand White rabbits for 24 h under occlusive conditions. No mortality occurred and thus a LD50 > 2000 mg/kg bw was determined. No data on clinical signs, body weight or gross pathology were given.

In general, alcohol ethoxylates are of low oral, dermal, and inhalation toxicity (HERA, 2009). The length of the alky chain had no meaningful influence on the toxicity. The degree of ethoxylation of the alcohol ethoxylates had some influence on the acute oral toxicity, with compounds with ethoxylate chains between 5 and 14 being more toxic than those with less than 4 or more than 15. In the available studies (n = 6) with a degree of ethoxylation of less than 4, which would correspond to the breakdown products ofAlcohols, C16-18, ethoxylated, phosphates, the LD50 were all greater than 6000 mg/kg bw (HERA, 2009).

Furthermore, sulphates and phosphates of ethoxylated alcohols are expected to be not acutely toxic by the oral and dermal routes (EPA, 2009). Studies performed withAlcohols, C12-16, ethoxylated (4 EO)phosphate (CAS 39464-66-9) showed an oral LD50 of 6550 mg/kg bw and a dermal LD50 of 5010 mg/kg bw (Younger laboratories, 1992; EPA, 2003). Several data on alcohol ethoxy sulphates are available for the oral and dermal route indicating a low acute toxicity (Younger laboratories, 1992; HERA, 2003).

Conclusion

Based on the available information on breakdown products ofAlcohols, C16-18, ethoxylated, phosphates and the information gained from reports onsulphates and phosphates of ethoxylated alcohols, no acute toxicity is expected forAlcohols, C16-18, ethoxylated, phosphates.

References

Younger Laboratories (1992)Initial Submission: Toxicological Investigation Of: Ethfac - Sample # 251 b with Cover Letter dated 081492. US EPA, NTIS/OTS: 0538618.

 

 

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Based on information from structurally similar substances, the available data on oral and dermal toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.