Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
See attachment
Test type:
fixed dose procedure

Test material

Test animals

Species:
rat
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
other: 1% w/v methylcellulose
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Main study: 5 (male)
Main study: 5 (female)
Control animals:
no
Details on study design:
Preliminary sighting study: 1 female at 500 mg/kg; 1 female at 2000 mg/kg, followed by the test itself

Results and discussion

Preliminary study:
Species/strain: Rats (CD)
2000 mg/kg bw: Evident toxicity: Y; Mortality: N
500 mg/kg bw: Evident toxicity: Y; Mortality: N

Observations:
Clinical signs observed at 500 and 2000 mg/kg comprised piloerection, hunched posture, waddling/unsteady gait, protruding eyes, lethargy, pallid extremities and at 2000 mg/kg only, abnormal respiration, walking on toes, eyes dull in colour and ungroomed appearance. There were no other signs of reaction to treatment and recovery was complete in both animals by Day 5.

Bodyweight gain was considered satisfactory and there were no macroscopic abnormalities noted at termination on Day 8.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5. Test not conducted on doses > 2000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5. Test not conducted on doses > 2000 mg/kg bw
Mortality:
0
Clinical signs:
Signs of toxicity:
Clinical signs of reaction to treatment characterised by piloerection in all rats was evident within six minutes of dosing. Piloerection persisted and was accompanied on Day 1 or at later intervals by hunched posture, waddling/unsteady gait, lethargy, pallid extremities, abnormal respiration, walking on toes, eyes dull in colour, ungroomed appearance, prostration (collapsed state), increased lacrimation and partially closed eyes in males and females. Protruding eyes, increased salivation and blue/cold extremities were notable among males only. Recovery was complete by Day 5.

All rats were considered to have achieved satisfactory bodyweight gains during the study.
Gross pathology:
Effects on organs:
Macroscopic examination of animals killed on Day 15 revealed no abnormalities.
Other findings:
There were no deaths.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute lethal oral dose to rats of CI-TTA Solid was demonstrated to be greater than 2000 mg/kg bodyweight..
CI-TTA Solid will not require labelling with the risk phrase R22 "Harmfull if swallowed" , in accordance with Commission Directive 93/2l/EEC, equivalent to Hazard statement H302 in accordance with REGULATION (EC) No 1272/2008.