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Diss Factsheets

Administrative data

Description of key information

A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw. No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. The LD50 after oral and dermal administration is therefore considered to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to OECD guidelines and GLP
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
Details on test animals or test system and environmental conditions:
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 10 weeks
- Fasting period before study: 16h before administration
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
unchanged (no vehicle)
2000 mg/kg bw
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration and at least once during each workday thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
No mortality occurred in both administration groups.
Clinical signs:
other: No clinical signs were observed in both administration groups during clinical examination.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period
Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

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
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Additional information

In an acute dermal toxicity study, young adult Wistar rats were dermally exposed to a single dose of 2000 mg/kg bw to the clipped skin and covered by semi-occlusive dressing for 24 hours. The animals were observed for 14 days. No mortality occurred. No signs of systemic toxicity were observed. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the undiluted test item were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females). No mortality occurred. No mortality occurred. There were no macroscopic pathological findings in all animals at the end of the observation period. The acute oral LD50was calculated to be > 2000 mg/kg bw.

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.