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:
other: study performed according to OECD and GLP guidelines, test result not conclusive
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
500 and 2000 mg/kg
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: LD50 not determined
Effect level:
<= 500 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Single dose administration of 2000 mg/kg or 500 mg/kg induced laborious or stertorous

breathing or increased salivation. Several animals died or were sacrificed in a

moribund condition within a few days after dosing. In general, the cause of poor

condition or death of the rats remained unclear. The findings in the gastrointestinal

tract are indicative of functional disturbances. The marked difficulties in breathing might

be due to the distention of the stomach, although it was not noted in all affected

animals. The pathogenesis of the tubulonephrosis observed in one female is unclear. It

might be related to the extreme body weight loss probably with resulting dehydration

observed in this animal.

Applicant's summary and conclusion

Interpretation of results:
other: substance is considered to be harmful or toxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
According to OECD or EU guidelines for chemicals, Zeanyne salt is considered to
be harmful if swallowed. The LD50 is estimated to be <2000 mg/kg > 500mg/kg
Executive summary:

The acute oral toxicity of Zeanyne salt was investigated in Wistar rats (5 rats/sex/group).

Single dose administration of 500 mg/kg or 2000 mg/kg of Zeanyne salt induced laborious or stertorous breathing or increased salivation. At 2000 mg/kg, 7/10 rats and at 500 mg/kg, 2/10 rats died or were sacrificed in a moribund condition

within a few days after dosing. At necropsy, a distention of the gastrointestinal tract and/or an abnormal intestinal content were found in some of the rats which died or were sacrificed prematurely. These findings are indicative of functional disturbances.

Microscopic findings in the lungs and kidneys observed in individual animals are considered not to be directly related to treatment.

Single dose administration of 500 mg/kg in the rat induced severe adverse effects and deaths. In general, the cause of poor

condition or death of the rats is unclear.