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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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, but followed principles thereof. Since the test substance is a strong alkaline substance, study results can be regarded as valid.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: CFR/USA Title 16, 1500.41

Deviations:

no

Principles of method if other than guideline:

Method: other: acc. to Draize Test

GLP compliance:

no

Remarks:

prior to GLP

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml undiluted

Duration of treatment / exposure:

24 hour(s)

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: gauze with non irritating tape. Additionally, the whole trunk was wrapped with an impermeable rubber blanket for 24 hours to avoid evaporation of volatile substance


REMOVAL OF TEST SUBSTANCE
- Washing : not reported
- Time after start of exposure: not reported


SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

> 8

Max. score:

8

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: irritation index could not be calculated, but in all animals (intact and abraded skin) black-coloured necrosis occurred

Irritant / corrosive response data:

Dry black-coloured necrosis was observed. No derivation of a primary irritation index was possible.

Any other information on results incl. tables

The extrapolation to 4-h exposure is limited: Based on current standards, the finding does not allow to conclusively assess whether reversible lesions or necrosis would result.

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Six rabbits exposed for 24 hours to 0.5 mL test substance under occlusive condition revealed black-colured necroses on the intact and abraded skin
were observed up to 72 hours after patch removal. Reversibilty of the necrosis cannot be judged because observation time was limited to 72 hours. Therefore, the substance is regarded to be corrosive.