Reaction mass of bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May. 14, 1979 to Jun. 5, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

-non-GLP study with non-OECD 404 testing protocol: 24h occlusive wrapping

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate

EC Number:

915-687-0

Cas Number:

1065336-91-5

Molecular formula:

unspecified

IUPAC Name:

1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate

Details on test material:

- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland
- Age at study initiation: Not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet: Standard rabbit food, NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 14 hrs dark/10 hrs light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved with or without abrasion

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

Single exposure for 24 hours

Observation period:

7 days

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: abraded and intact skin (back and flank)
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: Gauze patches (with the test material) were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
the shaven skin on one side was slightly scarified with the help of a "Schropfschnapper", Aesculap, Switzerland.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: Dressings were removed 24 hours after application.

SCORING SYSTEM: Same as the scale provided in the OECD guideline.
Calculation of the primary skin irritation index: The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.

Assessment of Irritation:
0 = none
>0 – 1 = minimal
>1 – 2 = slight
>2 – 4 = moderate
>4 – 6 = marked
>6 – 8 = extreme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.05

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

1

Reversibility:

fully reversible within: 3 days

Irritant / corrosive response data:

The calculated primary irritation index was 0.47. Test substance was found to cause a minimal irritation when applied to intact and abraded rabbit skin. The mean group score for erythema was 0.66, 0.66 and 0 for intact skin after 24, 48 and 72 hours, respectively. The mean group score for edema was 0.17, 0 and 0 for intact skin after 24, 48 and 72 hours, respectively.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was found to be not irritant to the skin under the test conditions applied.