Reaction mass of abieta-8,11,13-trien-18-yl [({[(abieta-8,11,13-trien-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate, abietan-19-yl [({[(abieta-8,11,13-trien-18-yloxy)carbonyl]amino}methyl)-polyalkylalicycleyl]carbamate, abieta-8,11,13-trien-18-yl [({[(abiet-13-en-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate, abiet-13-en-18-yl [({[(abiet-13-en-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate, abietan-19-yl [({[(abiet-13-en-18-yloxy)carbonyl]amino}methyl)-polyalkylalicycleyl]carbamate, abietan-18-yl [({[(abietan-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 24-27, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed in accordance with OECD guideline 404 (1992) and meets the requirements of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): CORSAIR CLEAR 34 resin
- Physical state: clear, brittle solid
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: young adult
- Housing: singly housed
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100
- Type of wrap if used: 4-ply gauze pad wrapped with Micropore tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped with water and a clean towel
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

average erythema + average edema

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the classification system (Draize scoring system) used, the test substance is classified as non-irritating to the skin.