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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Sex and age: Males, young adult
Lighting: 12 h light/ 12h dark cycle
Temperature during testing: 20 ± 3 ° C
Humidity: 35-70%
Ventilation: ca 10 air changes/hour

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml (0.056 g; density determined to be 0.56kg/l)

Duration of treatment / exposure:

7 Days

Observation period (in vivo):

7 Days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

7 d

Score:

> 0 - <= 1

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

At 1 hour after treatment, slight iritis (Two rabbits), slight or moderate redness and slight or moderate ocular discharge were observed in the three rabbits.
At 24 hours after treatment, rabbit no.48 showed slight corneal opacity, severe redness and slight or moderate swelling of the conjuntivae and moderate ocular dishcarge, whereas only slight redness of the conjuntivae were observed in the other two rabbits.
At 48 and 72 hours after treatment, rabbit no 48 showed slight corneal opacity, severe redness and slight swelling of the conjuctivae, whereas only slight redness of the conjunctivae was observed in the other two rabbits at 48 hours.
At 7 days after treatment, all eye effects had cleared completely.

Any other information on results incl. tables

  Mean values for corneal opacity, iritis, redness and swelling of the conjuncivae of each rabbit scored at 24, 48 and 72 hours after treatment.

Animal No       Opacity       Iritis       Redness       Swelling

44                     0.0              0.0           0.7              0.0

46                     0.0              0.0           0.7              0.3

48                     0.3              0.0          2.7              1.3

The undiluted substance caused slight corneal opacity, slight iritis, slight to severe redness and slight or moderate swelling of the conjunctivae and slight or moderate ocular discharge in the three rabbits. At 7 days after treatment all eye effects had cleared completely.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993) the compound is not irritating to human eyes.