2,2,6,6-tetramethyl-4-piperidylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed prior to OECD guideline and GLP principles but follows principles thereof.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: CFR 16, 4500.42

Deviations:

no

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Remarks:

Study was perfomed prior to GLP settings

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethyl-4-piperidylamine

EC Number:

253-197-2

EC Name:

2,2,6,6-tetramethyl-4-piperidylamine

Cas Number:

36768-62-4

Molecular formula:

C9H20N2

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-amine

Details on test material:

Name of test material (as cited in study report): Triacetondiamin
- Substance type: colourless liquid with low viscosity
- Physical state: liquid
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: J. Scheele, Büdrich/Westfalen, Werl, Germany
- Housing: individually
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
Temperature: 21-23°C
climated rooms
light circle dark/light: 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

Single instillation into the conjunctival sac; The test item was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. No rinsing was performed.

Observation period (in vivo):

Due to the observed effects all animals were killed after 24 h after application for human reasons

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
According to Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics published by the Food and Drug Officialy of the United States, 1959

TOOL USED TO ASSESS SCORE: no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

4

Max. score:

4

Remarks on result:

other: animals killed after 24 h for human reasons

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h

Score:

> 2

Max. score:

2

Remarks on result:

other: not assessable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness and chemosis

Basis:

mean

Time point:

other: 24 h

Score:

> 4

Max. score:

4

Remarks on result:

other: black discolouration

Irritant / corrosive response data:

total irritation could not be calculated. After 24 h, high-grade irritation associated with strong swelling and black-coloured necrosis of the conjunctivae as well as complete opacity of the corneas in all animals.

Applicant's summary and conclusion

Interpretation of results:

Category I

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Six rabbits exposed for 24 hours to 0.1 mL test substance in the conjuncital sac revealed high-grade irritation associated with strong swelling and black-coloured necrosis of the conjunctivae as well as complete opacity of the corneas in all animals. Therefore, under conditions tested, the test substance is regarded to be corrosive.