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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral (similar to OECD 401), rat: LD50 > 20 mL/kg bw (corresponding to > 17400 mg/kg bw based on a density of 0.87 g/cm³; limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no information on test substance purity, limited documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no information on test substance purity, limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 155 - 195 g
- Fasting period before study: 16 h prior to dosing
- Housing: in macrolon plastic cages, wood chips bedding
- Diet: commercial pellets (Ssniff/Intermast Standard, Soest, Germany)
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
20 mL/kg bw (corresponding to 17400 mg/kg bw based on a density of 0.87 g/cm³)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortalities at intervals on the day of dosing and at least once daily thereafter for an entire period of 14 days. Body weight was recorded on day of administration and on Day 14 before sacrifice.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Remarks on result:
other: LD50 > 17400 mg/kg bw based on a density of 0.87 g/cm³
Mortality:
No mortality occurred during the study period.
Clinical signs:
No toxicity symptoms were observed.
Body weight:
No effect on body weight gain was noted.
Gross pathology:
No pathological-anatomical changes were found in the cranial-, thoracic- and abdominal cavity during the section.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value > 20 mL/kg bw (corresponding to > 17400 mg/kg bw based on a density of 0.87 g/cm³) in male and female rats was found.
Executive summary:

The acute oral toxicity of the test substance was assessed in a study similar to OECD Guideline 401 (1979).10 male and 10 female rats were administered a single dose of 20 mL/kg bw via gavage. No mortality occurred within 14 days. Thus, a LD50 > 20 mL/kg bw (corresponding to > 17400 mg/kg bw based on a density of 0.87 g/cm³) was derived.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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

The acute oral toxicity of the test substance was assessed in a study similar to OECD Guideline 401 (1979). 10 male and 10 female rats were administered a single dose of 20 mL/kg bw via gavage. No mortality occurred within 14 days. Thus, a LD50 > 20 mL/kg bw (corresponding to > 17400 mg/kg bw based on a density of 0.87 g/cm³) was derived.

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.