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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:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Principles of method if other than guideline:
Annex V to Council Directive 67/548/EEC on the approximation

of laws, regulations and administrative provisions relating

to the classification, packaging and labelling of dangerous

substances, published in the Seventeenth Adaptation,
Commission Directive 92/69/EEC, OJEC L383A, 113-116, 1992.
(B.1 bis Acute Toxicity (Oral) Fixed Dose Method).
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Rat - Wistar (Alpk:APfSD)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% w/v aqueous carboxymethylcellulose
Doses:
Dose 300mg/kg 50 mg/kg

Number animals 1 5

No. of animals per sex per dose:
Preliminary sighting study: 0 (male)
Preliminary sighting study: 1 (female)
Main study: 0 (male)
Main study: 5 (female)
Details on study design:
Main study:
50 mg/kg

Results and discussion

Preliminary study:
Species/strain: Rat - Wistar (Alpk:APfSD)
300 mg/kg bw: Evident toxicity: Y; Mortality: Y
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
50 mg/kg bw
Remarks on result:
other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5
Clinical signs:
Signs of toxicity:
No deaths. Signs of toxicity on day 1 only.
Gross pathology:
Effects on organs:
None
Other findings:
Dose 300mg/kg 50 mg/kg

Number animals 1 5

sex female female

mortality 1 0


Clinical signs :

prostration splayed gait

tremors Piloerection, lacrymation

cyanosis Salivation, stained nose,

reduced splay reflex


Gross necropsy :

no macroscopic no macroscopic

effects effects

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information