Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No study is available for the submission substance: a study is available for the read-across substance ethoxylated propylidynetrimethanol (TMP EO).

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch score = 1. Modern study compliant with current test guidelines and GLP
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Studies on the reproductive toxicity of a 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 a reproductive toxicity study on 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 in accordance with EU Directive 86/609/EEC.

The reproductive toxicity of TMP EO was investigated in an OECD Test Guideline 421 reproductive/developmental toxicity screening study in which rats received the test substance via oral gavage at 0, 100, 300 or 1000 mg/kg bw/day for 4 weeks (Buesen, 2010). No treatment related effects were observed on reproductive or developmental parameters. The NOAEL (no observed adverse effect level) for reproductive performance and fertility was 1000 mg/kg body weight/day for the F0 parental rats (e.g. the highest dose tested). The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg body weight/day for the F0 parental animals (e.g. the highest dose tested). The NOAEL for developmental toxicity in the F1 progeny of treated groups was found to be 1000 mg/kg body weight/day (e.g. the highest dose tested). No reproductive or developmental effects with observed in a screening study on TMP EO. Based on read-across to this study, no reproductive or developmental toxicity is predicted for Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Quality of whole database:
Klimisch score = 1. Modern study compliant with current test guidelines and GLP
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Studies on the developmental 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 a developmental toxicity study on ethane-1,2-diole, propoxylated (MEG PO) 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 in accordance with EU Directive 86/609/EEC.

In a pre-natal developmental toxicity conducted according to OECD Test Guideline 414, female Wistar rats were treated with MEG PO daily via oral gavage at 0, 100, 300, and 1000 mg/kg body weight in demineralised water from day 6 to day 20 p.c (Langewische, 2010). No treatment related effects were observed on developmental parameters. NOAELs of 1000 mg/kg bw/day (e.g. the highest dose tested) were determined for maternal toxicity and for developmental toxicity respectively.

There is no evidence from a pre-natal developmental toxicity study using MEG PO or a developmental screening study using TMP EO to indicate that these substances are developmental toxicants. Based on read-across to these studies, no developmental toxicity is predicted for Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy.


Justification for selection of Effect on developmental toxicity: via oral route:
Based on existing datasets and structural and chemical considerations, read-across from the substance to a pre-natal developmental study using ethane-1,2-diole, propoxylated (MEG PO) is appropriate to meet the REACH Annex VII-IX data requirements. No developmental effects were observed in the study: the NOAEL was 1000 mg/kg bw. Based on read-across, no reproductive toxicity is predicted for the substance.

Justification for classification or non-classification

The results of a reproductive/developmental screening study on propylidynetrimethanol, ethoxylated (TMP EO) and a pre-natal developmental study on ethane-1,2-diole, propoxylated (MEG PO) do not indicate these substances are reproductive or developmental toxicants. Based on read-across to these studies Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- is not predictedto have potential to cause developmental or reproductive toxicity. The substance does not meet the criteria for classification for developmental or reproductive toxicity according to according to Directive 67/548/EEC or Regulation 1272/2008/EC.