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Toxicological information

Acute Toxicity: oral

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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:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Gavage administration of limit dose 5000 mL/kg bw to each 5 male and female rats; Investigation of clinical signs, body weights and mortality; Duration of observation period following administration: 14 days; Necropsy of survivors performed at termination of study
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Bor: WISW (SPF Cpb)
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: approx. 9 (males) and 14 (females) weeks
- Weight at study initiation (mean): males 199 g, females 169 g
- Fasting period before study: Food was withheld from the animals for approx. 16 h before test substance administration until approx. 4 h after test substance administration.
- Housing: in groups of five in Makrolon type III cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mL/kg bw eq. to 6000 mg/kg bw (density 1.2 g/mL)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality were checked several times on the day of administration and twice daily thereafter (exemption: once on week-ends and holidays). Body weights were determined on the day of administration, after one week and at termination of the study.
- Necropsy of survivors performed: yes, all animals were necropsied at the end of study.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mL/kg bw
Remarks on result:
other: eq. to > 6000 mg/kg (density 1.2 g/mL)
Mortality:
Mortalities were not observed during the study.
Clinical signs:
None of the male or female animals showed clinical signs during the study.
Body weight:
No effects on body weights reported.
Gross pathology:
Gross necropsy revealed no test-substance related findings.

Applicant's summary and conclusion

Executive summary:

For assessment of acute oral toxicity a limit test is available. In this study 5 male and 5 female rats were gavaged once at a dose of 5000 mL/kg bw (eq. to 6000 mg/kg bw; density 1.2 mg/mL). Animals were observed for a 14 -days period for clinical signs and mortality, furthermore necropsy was performed at study termination.

Mortalities and clinical signs did not occur in the course of the study. Gross necropsy revealed no test-substance related findings. The LD50 was therefore concluded to be > 5000 mL/kg bw.