Registration Dossier

Administrative data

Description of key information

No acute oral toxicity data are available for the submission substance. Read-across data are available for the read-across substances propoxylated propylidynetrimethanol (TMP PO) and ethoxylated propylidynetrimethanol (TMP EO).

A waiver is presented for acute inhalation toxicity: pnhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the submission substance.

No acute dermal toxicity data are available for the submission substance. Read-across data are available for the read-across substance propoxylated propylidynetrimethanol (TMP PO).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
Klimisch score = 1. Modern study compliant with current test guidelines and GLP

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
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch score = 1. Modern study compliant with current test guidelines and GLP

Additional information

Studies on the acute toxicity of Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-are not available. Based on existing datasets, structural and chemical considerations, read-across from the substance to acute toxicity studies on propylidynetrimethanol, propoxylated (TMP PO) and to propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing.

Acute oral toxicity

In a study conducted according to OECD Test Guideline 423 (Acute toxic class method), the acute oral LD50 of TMP PO was determined to be greater than 2500 mg/kg bw in rats (ISOPA, 2002). In an OECD Test Guideline 401 acute oral toxicity study, the acute oral LD50 value for TMP EO was > 5000 mg/kg bw in rats (Gardiner, 1988). TMP PO and TMP EO have low acute oral toxicity. Based on read-across, similar low acute oral toxicity is predicted forPoly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-

Acute dermal toxicity

The acute dermal LD50 of TMP PO was determined to be >2000 mg/kg bw in rats in a study conducted according to OECD Test Guideline 402 study (ISOPA, 2002). TMP PO has low acute oral and dermal toxicity. Based on read-across, similar low acute dermal toxicity is predicted forPoly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-

Acute inhalation toxicity

A waiver is proposed for acute inhalation studies in accordance with Column 2 of Annex VIII of the REACH Regulation for this endpoint on the basis that the substance is predicted to have low potential to exert acute toxicity via the oral and dermal routes.  Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance. The substance is a non-volatile liquid and the use pattern indicates that significant inhalation exposure is unlikely. No additional testing is therefore warranted.


Justification for selection of acute toxicity – oral endpoint
Based on existing datasets, structural and chemical considerations, read-across from the substance to acute toxicity studies on propylidynetrimethanol, propoxylated (TMP PO) and to propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to meet the REACH Annex VII-IX data requirements. In the key study: an acute oral toxicity study using TMP PO conducted in accordance with OECD Test Guideline 423, the LD50 was determined to be > 2500 mg/kg bw.

Justification for selection of acute toxicity – dermal endpoint
Based on existing datasets, structural and chemical considerations, read-across from the substance to acute toxicity studies on propylidynetrimethanol, propoxylated (TMP PO) and to propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to meet the REACH Annex VII-IX data requirements. In the key study: an acute dermal toxicity study using TMP PO conducted in accordance with OECD Test Guideline 402, the LD50 was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

Based on read-across to acute oral and dermal toxicity studies on propylidynetrimethanol, propoxylated (TMP PO) and on propylidynetrimethanol, ethoxylated (TMP EO) , the substancePoly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- is predicted to have low inherent acute toxicity.The substance does not meet the criteria for classification for acute oral or dermal toxicity according to Regulation 1272/2008/EC.