Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No study on acute oral toxicity is available for the substance. A range finder study in rats, initially conducted with gavage administration, revealed that the substance was retained in the rat stomach, possibly due to a low solubility under acidic stomach conditions. Subsequently, animals at doses from 500 to 1000 mg/kg bw died or had to be killed interim due to animal welfare obligations. At necropsy a build-up of the test substance (yellow compacted mass) was observed in the stomach. No indications for a systemic effect could be identified. Due to these technical problems and taking into account animal welfare considerations, an acute oral toxicity study with gavage doses up to the highest dose of 2000 mg/kg bw was omitted.

However, a reliable assessment on acute oral toxicity can be made based on the result of a repeated dose (28 -day) toxicity study with diets containing 500, 1000 and 2500 ppm test substance (adjusted for purity), equivalent to an estimated mean achieved dosage of approx. 45, 88 and 212 mg/kg bw/day (adjusted for purity) for males and 45, 88 and 213 mg/kg bw/day (adjusted for purity) for females.

It is important to note that 2500 ppm was the highest dietary concentration that was practical to test, as higher levels were precluded due to the decreased food consumption considered to reflect the palatability of the dietary formulations.

The human relevant NOAEL in the repeated dose study was 2500 ppm (approx. 212 mg/kg bw). Scientific evidence exists that a NOAEL of >/= 200 mg/kg bw will lead to a LD50 for acute oral toxicity of > 2000 mg/kg bw (Bulgheroni et al., Regulatory Toxicology and Pharmacology 53, 16 -19, 2009). This estimation of acute oral toxicity seems to be appropriate here, since the available data demonstrate for the substance a low toxicity profile with no indications for an irritant or genotoxic potential (test battery for skin sensitisation not completed yet) and with no human relevant effects at repeated dose feed studies up to the highest concentration tested (OECD 407: solely rat specific alpha2µ-globulin kidney effects in male rats at highest dose tested and OECD 421: no adverse effects for general toxicity, fertility and developmental toxicity).

Summarizing, the predicted oral LD50 is for the substance > 2000 mg/kg bw.

No study on acute inhalation toxicity is available for the substance.

No study on acute dermal toxicity is available for the substance. According to REACH Regulation (EU) Annex 2016/863 such a study is only required if a substance meets the criteria for classification for acute toxicity or STOT SE by the oral route. Therefore, the conduct of a dermal toxicity study is waived, and the assessment of dermal toxicity is based on the oral toxicity assessment and on the other available information of the test substance.

The substance has a molecular weight of 720. 4 g/mol, which is in a range not favourable for dermal absorption. On the other hand, the good water solubility (240 g/L) might facilitate absorption through the skin. The assessment of acute oral toxicity led to a concluded LD50 of > 2000 mg/kg bw. Furthermore, the available data on skin/eye irritation/corrosion does not give evidence for a skin irritant potential that might facilitate absorption through the skin barrier.

Therefore, it is not expected that systemic availability after dermal exposure would be higher than after oral exposure. Based on the weight of evidences the conclusion can be drawn that for acute dermal toxicity no hazard is expected. This is in line with REACH Annex VIII (8.5.3) (Reg. (EU) 2016/863) that considers toxicity testing by the dermal route as not needed if a substance does not meet the criteria for classification as acute toxic by the oral route, and with further publications (Moore, Regulatory Toxicology and Pharmacology, 2013, 66, 30-37; Creton, St. et al, Critical reviews in Toxicology, 2010, Vol. 40 No.1, pages 50-83).

Justification for classification or non-classification

No classification concluded for Acute Toxicity according to Regulation (EC) No 1272/2008, Annex I.