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

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: 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 wi

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.