Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
male/female
Details on test animals 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

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.