Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Subcutanueous rat: TDLo: 450 mg/kg/3D-I, Changes in uterine weight (Toxicology Letters, Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands V.1-1977-167,1,2006)

Structural alert (repeated dose, HESS) in OECD QSAR Toolbox (version 4.1): hepatotoxicity

Read-across data captured from published Benzophenone registration dossier:

Oral rats 14 weeks (OECD Guideline 408): NOAEL <75/85 mg/kg bw (in males/females; low dose): Treatment-related increases in liver weights were attributed to hypertrophy and/or cytoplasmic vacuolization of hepatocytes. Increased kidney weights were associated with a spectrum of renal changes in exposed males and females. Clinical chemistry analyses confirmed liver toxicity. Biochemical data indicated that benzophenone was a relatively potent inducer of the phenobarbital-type (2B) cytochrome P450 enzymes. (Unnamed publication, 2000)

Oral mice 14 weeks (OECD Guideline 408): NOAEL <200/275 mg/kg bw (in males/females; low dose): same liver toxicity (Unnamed publication, 2000)

Oral rats 90 days (OECD Guideline 408): NOEL 20 mg/kg bw (in males/females; only dose tested for 90 days) (Burdock et al., 1991, Food Chem Toxicol 29, 741-750)

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available read-across data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EU) No 2015/1221. Administration of the read across substance Benzophenone in several oral long-term studies in rats and mice led to increased relative liver and kidney weights, hepatocellular enlargement with an associated clumping of cytoplasmic basophilic material around the central vein with doeses above 20 mg/kg bw/d (NOAEL). Benzophenone is at least in part metabolized to 4 -hydroxy-benzophenone, so similar properties of the registered substance cannot be excluded. Furthermore there was a structural repeated dose (HESS) alert in the OECD QSAR Toolbox (version 4.1) for hepatotoxicity of 4-hydroxy-benzophenone. As a result the substance is considered to be classified for specific target organ toxicity after repeated exposure (STOT RE) cat. 2 (H373) liver and kidney.