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Diss Factsheets

Administrative data

Description of key information

The LD50 value of the test item determined to be greater than 2000 mg/kg bw in rats after oral administration (OECD 401).

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:
15 January 1997 - 29 January 1997
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
February 1987
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
other: HsdCpb:WU
Details on test animals or test system and environmental conditions:
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: about 7 and 8 weeks
- Weight at study initiation: 151 - 159 g (females), 178 - 189 f (males)
- Fasting period before study: Food was withheld from about 17 hours before dosing up to 4 hours after treatment.
- Housing: separately in Makrolon cages type III (floor area: 37.5 x 21cm = 787.5 cm2, height: 15 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

- Temperature (°C): 21 to 22
- Humidity (%): 31 to 66 (The relative atmospheric humidity in the animal room were transiently outside the target range of 45 to 75%. This minor and short deviations did not influence the integrity of the study.)
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
other: aqueous Methocel K4M Premium solution
Details on oral exposure:
- Concentration in vehicle: 100 mg/mL


2000 mg/kg bw
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: All rats were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the inlife-phase. The behaviour and general condition of all rats were monitored for at least 6 hours after the administration and then checked daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
The body weight data and the clinical findings were processed by means of a PC - pro gram, developed by the Institute of Toxicology of Merck KGaA, Darmstadt. The body weight development of each rat and group was determined. The group mean value and the difference to the initial value, expressed as percentage, were calculated for each measurement and printed out on tables.
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
All the rats survived the observation period.
Clinical signs:
other: No signs of intoxication occurred after treatment.
Gross pathology:
At necropsy, no organ alterations were seen.
Interpretation of results:
GHS criteria not met
The LD50 of the test item was determined to be greater than 2000 mg/kg bw in rats after oral administration.
Executive summary:

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before the administration the test material was prepared with aqueous Methocel K4M Premium solution.

No signs of intoxication were detected after treatment and no rat died. Thus, the study was performed as limit test. The gross pathological examination revealed no organ alterations. For regulatory purposes, the median lethal dose (LD50), after an observation period of 15 days can be declared as > 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
Guideline study under GLP conditions

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

Justification for classification or non-classification

Based on the available data, the test item is not considered to be classified and labelled for acute oral toxicity according Regulation (EC) No 1272/2008.