Registration Dossier

Diss Factsheets

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: The study is quite old and not performed to current guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA: Toxic substances guideline, HG Acute oral. October 1984
Deviations:
not specified
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine
EC Number:
500-311-6
EC Name:
N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine
Cas Number:
120498-03-5
IUPAC Name:
1,3-Propanediamine,N-N’’-1,2-ethanediylbis- reaction product with 1,3,5-triazine-2,4-diamine,N,N’-dibutyl-6-chloro-N,N’-bis(2,2,6,6-tetramethyl-4-piperidinyl), polymer with N-butyl-4,6-dichloro-N-(2,2,6,6-tetramethyl-4-piperidinyl)-1,3,5-triazin-2-amine
Details on test material:
Name of test material (as cited in study report): TABANOL 4

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
15 males + 15 females aged 7 - 9 weeks - body weight (males and females) 200 - 225g. Amimals were acclimitased for atleast 5 days before the beginning of the test.
Housing- 5 animals/sex/cage in air conditioned rooms: Temp 22 ± 2 ° C, relative humidity 60 ± 20 %, Air changes ca 12 hour filtered on HEPA 99.97%, cage size: makrolon cages 42x26x15.4cm

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
The test article was admisistered as follows:
Dose mg/kg Administration volume ml/kg Treatment date
1600 4 4th November 1987
2400 4+4 17th November 1987
3200 4+4 10th November 1987
Doses:
The doses of 2400mg/kg and 3200mg/kg was administered in two seperate fractions, the second 4 hours after the first one.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Statistics:
Calculation not possible

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 3 200 mg/kg bw
Based on:
test mat.
Mortality:
1 Male died in dose group 2400 mg/kg within 30 mins of treatment
1 Female died in dose group 3200 mg/kg within 48 hours of treatment
Clinical signs:
Piloerection and irregular bleeding with grasping were the main clinical signs observed, starting 30 mins after treatment, in rats treated at 2400 mg/kg and 3200 mg/kg
A few animals of these dosages also showed slight sedation
The female rat which died within dosage 3200 mg/kg showed before death tachypnea and red nostril discharge
The clinical signs disappeared, in general, within 24-72 hours. One male rat treated at 2400 mg/kg showed gasping up to day 8
A few rats treated at the lower dosage (1600 mg/kg) showed only piloerection starting from day 3 up to day 5
Body weight:
Decrease in body weight was recorded on day 8 in one male rat treated at 2400 mg/kg.
No modification in body weight gain was observed in other surviving animals.
Gross pathology:
Animals that died during the observation period:
Male rat dosed at 2400 mg/kg showed marked congestion of lungs
Female rat dosed at 3200 mg/kg showed slight congestion of lungs and diffuse pulmoary emphysema.
Animals killed at end of observation period showed no alterations

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article TABANOL 4, when administered by oral route to rats under teh experimenatl conditions applied in this study, showed an LD50 higher than 3200 mg/kg.
The gross pathology of the animals killed at the end of the observation period did not show any changes.