Dodecanedioic acid, 1,12-bis[2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl] ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8th April 2013- 3rd July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate

EC Number:

939-042-8

Cas Number:

1482217-03-7

Molecular formula:

C58H56N6O8

IUPAC Name:

1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): T-1620L
- Physical state: pale yellow powder
- Analytical purity: 99.9%
- Lot/batch No.: OF1211
- Expiration date of the lot/batch: 30 April 2013
- Storage condition of test material: RT in the dark
- Other:

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 33-48 weeks
- Weight at study initiation:3.06 to 4.13 kg
- Housing: housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Each rabbit was offered 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16-28 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light

IN-LIFE DATES: From: To: 08 April to 03 July 2013

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g, area wetted with 0.5 mL reverse osmosis water beforehand
- Concentration (if solution): N/a

Duration of treatment / exposure:

4-hour exposure

Observation period:

4 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 100%
- Type of wrap if used: a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water (30-40°C)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Local dermal irritation was assessed using the prescribed numerical system and a primary irritation index (PTI) calculated from the scores

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

There was no sign of toxicity or ill health in any rabbit during the observation period. No dermal reaction was observed in any animal throughout the duration of the study

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The Primary Irritation Index was calculated to be 0.0; T-1620Lwas classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008

Executive summary:

The Primary Irritation Index was calculated to be 0.0; T-1620Lwas classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008