Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate

Specific investigations: other studies

Administrative data

Endpoint:

phototoxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Half an hour after dermal application the animal was fixed in front of the light source in an animal holder at a distance of 5.6 cm from the lamp box and a circular skin area of 1 cm in diameter of one side of the mouse was exposed to UV-light for a duration of 2 minutes. The contralateral side, not exposed to light, served as the control. The skin reactions were evaluated 24, 48 and 72 h after the irradiation according to the Draize Scoring system for primary irritation reactions.

GLP compliance:

no

Type of method:

in vivo

Endpoint addressed:

skin irritation / corrosion

Test material

Test material information

Constituent 1

Reference substance name:

Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate

EC Number:

264-513-3

EC Name:

Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate

Cas Number:

63843-89-0

Molecular formula:

C42H72N2O5

IUPAC Name:

bis(1,2,2,6,6-pentamethylpiperidin-4-yl) 2-butyl-2-[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]propanedioate

Details on test material:

- Physical state: solid
- Analytical purity: no data provided
- Lot/batch No.: EN 21175

Test animals

Species:

mouse

Strain:

other: hairless HR/HR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bomholtgard
- Age at study initiation: 2 - 2.5 months old
- Weight at study initiation: 20 - 27 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1
- Humidity (%): 50 ± 5
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:

dermal

Vehicle:

other: 50% Acetone / 50% Ethanol

Details on exposure:

TEST SITE
- Area of exposure: flanks

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL
- Concentration (if solution): 0.3%, 1% and 3%
- Constant volume or concentration used: yes
- For solids, paste formed: no

Half an hour after application the animal was fixed in front of the light source in an animal holder at a distance of 5.6 cm from the lamp box and a circular skin area of 1 cm in diameter of one side of the mouse was exposed to UV-light for a duration of 2 minutes. The contralateral side, not exposed to light, served as the control.

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

single treatment, not washed

Frequency of treatment:

once

Post exposure period:

72 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
0.3%, 1%, 3%
Basis:
nominal conc.

No. of animals per sex per dose:

3

Control animals:

yes, concurrent no treatment

Details on study design:

Light source characteristics:
Solar Ultraviolet Simulator (Solar Light Company, 6655 Lawnton Ave, Philadelphia, Pennsylvania 19126).
Burner: 150 W Xenon.
Wavelength range for irradiation: 320 - 400 nm.
Irradiation intensity at focused distance: 35 mW/cm²

Examinations

Examinations:

The skin reactions were evaluated 24, 48 and 72 h after the irradiation according to the Draize Scoring system for primary irritation reactions.

Positive control:

0.1% 8-methoxypsoralene (8-MOP)

Results and discussion

Details on results:

No adverse skin reaction was observed when the test substance was applied topically to hairless mice followed by UV-irradiation.
Moderate oedema reactions were seen 24 h after application of 0.1 % 8-methoxypsoralene topically to hairless mice followed by UV-irradiation. Fresh necrosis surrounded by erythema was observed 48 and 72 h after irradiation in the 0.1 % 8-methoxypsoralene group.

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions employed, the test substance was found to cause neither erythema nor edema in hairless mice when applied topically followed by UV irradiation. The test substance was found to be devoid of a phototoxic potency in hairless mice.