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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:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
RTC, Rome, Italy
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): N-Butyl-2,2,6,6-tetramethyl-4-piperidinamine (N-Butyl-TAD)
- Substance type: colourless liquid
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy, San Pietro al Natisone (UD), Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 176-200 g
- Fasting period before study: overnight before dosing
- Housing: 3 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days prior dosing


ENVIRONMENTAL CONDITIONS
according to guideline

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 and 30 mg/mL
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: soluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 and 300 mg/kg bw.
No. of animals per sex per dose:
3 (300 mg/kg bw was dosed in two steps with 3 animals each)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/morbidity: twice daily; observations: 30 min, 1 (except step 2 and 3), 2 and 4 h post application and daily thereafter; weighing immediately prior dosing, days 2, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off
Mortality:
2000 mg/kg bw: all animals died within 4 hours post application
300 mg/kg bw: no mortality in two groups of 3 females each
Clinical signs:
Reduced activity, hunched posture, lethargy semi to full closed eyes, piloerection, salivation and mucus in the litter tray, recovery occurred by day 2 at 300 mg/kg bw.
Body weight:
within the normal range
Gross pathology:
no abnormalities were observed in any animal at the necropsy examination

Any other information on results incl. tables

According to Annex 2d of OECD TG 423 an LD50 cut-off of 500 mg/kg bw could be derived.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under conditions tested, all animals died on the day of dosing at a dose level of 2000 mg/kg bw. At a dose level of 300 mg/kg bw, no mortality was observed. Main clinical findings were reduced activity, hunched posture, lethargy semi to full closed eyes, piloerection, salivation and mucus in the litter tray, recovery occurred by day 2 at 300 mg/kg bw.