Registration Dossier

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Administrative data

Key value for chemical safety assessment

Justification for classification or non-classification

Triboron trimethyl hexaoxide is expected to hydrolyse in contact with water to form methanol (CAS 67-56-1) and boric acid (CAS 10043-35-3) (Steinberg and Hunter, 1957). For both hydrolysis products relevant reproduction toxicity data was gathered from the ECHA dissemination dossier (d.d. 2014 -04 -25) and tabulated below. The classification of the parent substance is based on the worst case classification of both hydrolysis products.

 

Reproduction toxicity data for methanol:

 

Study

Species

Endpoint

Effect level

Two-generation study

Rat

NOAEC

0.13 mg/L air (based on reproductive parameter and brain weight (offspring))

Prenatal developmental toxicity study

Rat

NOAEC

1.33 mg/L air (based on maternal toxicity, fetal malformation, increased perinatal mortality and developmental delay in surviving progeny)*

* Lowest effect level of 15 WoE studies

 

Genetic toxicity data for boric acid:

 

Study

Species

Endpoint

Effect level

Three-generation study

Rat

NOAEL

100 mg/kg bw/day (based on reduced fertility at higher levels)

Prenatal developmental toxicity study

Rat

NOAEL

55 mg/kg bw/day (based on reduced fetal bodyweight, short and wavy ribs)

 

 

Based on the available information in the ECHA disseminated dossier and according to Annex VI of EC/1272/2008 boric acid is classified as May damage fertility or the unborn child (Repr. 1B, H360FD). According to Annex I of Directive 67/548/EEC boric acid is classified as May impair fertility and May cause harm to the unborn child (Repr. Cat. 2, R60 and R61). In accordance with Regulation EC/1272/2008 and Directive 67/548/EEC, methanol is not considered to be classified for reproduction toxicity.

The classification of triboron trimethyl hexaoxide needs to be Repr. 1B, H360FD (May damage fertility or the unborn child) in accordance with Regulation EC/1272/2008, and Repr. Cart. 2, R60 and R61 (May impair fertility and May cause harm to the unborn child) in accordance with Directive 67/548/EEC.

Additional information