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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral: LD 50 > 2000 mg/kg bw (OECD 423)
Acute dermal: LD 50 > 2000 mg/kg bw (OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Additional information

Acute toxicty (Oral)

 

In a GLP study Wistar rats were treated following the protocols of the acute toxic class method as described in the OECD guideline 423. The toxicity of the test item was assessed by stepwise treatment of two groups of female rats (3 animals per step). The first group was given a single oral (gavage) dose of 2000 mg/kg bw. Since no mortality was observed in the first group after a 14 day observation period, a second group of female rats were treated by gavage with another dose of 2000 mg/kg bw. Again no mortality was registered in the second group of females. LD 50 was established to be > 2000 mg/kg bw. The only clinical signs of toxicity included hunched posture noted in all females and piloerection noted in only one female on day 1 only. The mean body weight gain shown by the animals over the study period was considered to be normal. At necropsy, no macroscopic post mortem abnormalities were found (NOTOX B.V 2004; reliability = val. 1).

Acute dermal toxicity

In an GLP conform acute dermal toxicity study according to OECD 402 groups of 10 weeks old wistar rats (5/sex/dose) were treated with undilted test substance at a dose of 2000 mg/kg bw (1.63ml/kg). The test substance was applied at occlusive conditions to an area approximately 10 % (approx. 25 cm2 for males and 18 cm2 for female) of the total body surface. Animals were subsequently observed for a period of 14 days. No mortality occurred after 14 days of observation. LD 50 was established to be > 2000 mg/kg bw. Clinical signs of toxicity included flat and/or hunched posture, chromodacryorrhoea, lethargy and/or ptosis shown by most animals on days 1 and/or 2. Scales were seen in the treated skin-area of 3/10 animals (1♂, 2♀) between days 3 and 9. Body weight development during the 14 day observation period was normal. (NOTOX B.V 2005; reliability = val 1).

Justification for classification or non-classification

The test substance is virtually nontoxic after ingestion and dermal contact. The substance does not meet the criteria for classification according to 67/548/EEC and 1272/2008/EEC (EU-GHS).

No classification for inhalation due to the lack of data.