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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupranol VP 9234
- Molecular weight: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
8-12 weeks of age (males); 14-18 weeks of age (females); animals of comparable weight.
single housing with free access to drinking water and food throughout the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 and 200 mg/kg bw single dose
No. of animals per sex per dose:
three
Control animals:
no

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
3/3 males died during hour 2 or on study day 1. No mortality occurred in the 200 mg/kg dose groups (0/3 males; 0/3 females)
Clinical signs:
2000 mg/kg: impaired and poor general state, dyspnoea, apathy, staggering, cyanosis, salivation compulsory gnawing and piloerection (from hour 0 until hour 5 after administration)
200 mg: no signs of toxicity (males); salivation (one female, during hour 4 after administration)
Body weight:
The surviving animals showed expected body weight gains.
Gross pathology:
In one of the three male animals that died slight red discoloration in the small intestine was observed; no abnormalities were noted in 2 males that died and in the animals of the 200 mg/kg dose groups (3 males and 3 females)

Applicant's summary and conclusion

Conclusions:
The median lethal dose of the test substance after oral administration was found to be greater than 200 mg/kg and less than 2000 mg/kg b.w. for male and female rats.