HDI oligomers, oxadiazintrione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HDI oligomers, oxadiazintrione

IUPAC Name:

HDI oligomers, oxadiazintrione

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: HC:NZW
- Source: Interfauna UK Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2.8, 3.1, and 3.5 kg
- Housing: singly in wire mesh cages (Typ III) on low dust wood granulate bedding
- Diet and water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, the skin areas of the contralateral flank (treated with moistened plaster) served as control

Amount / concentration applied:

500 µL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

One day prior to test substance administration the contralateral skin areas of the flanks of 3 rabbits were shorn (approx. 6x6 cm).
On the day of administration 500 µL of the test item was given on a hypoallergenic plaster (Beiersdorf No. 2342) and applied onto the skin. For negative control a further plaster was moistened with water and applied to the skin of the opposite flank. Each treatment site was then covered with elastic dressings (Fixomull-Strech Klebevlies, Beiersdorf No 2039) under semiocclusive conditions. After the 4-hours exposure period dressings and plaster were removed and the treated skin areas washed with water.
Readings were after 1, 24, 48, and 72 hours and after 7 and 14 days.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean score: 1.3

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, #3

Time point:

other: 24, 48, 72 hours

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: at least 14 days

Remarks on result:

other: mean score: 1.7

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Applicant's summary and conclusion

Executive summary:

Dermal irritation/corrosion of the substance was tested according to OECD TG 404 on three rabbits. In this study 500 µL of the test item was applied semiocclusively on the previously shorn skin of the flanks. The opposite areas of the skin were used for negative control (plaster moistened with water, semiocclusive dressings). Readings were after a 4 hour-exposure period according to Draize at time points 1, 24, 48, and 72 hours and after 7 and 14 days.

The substance led to slight irritant effects after 24, 48, and 72 hours (mean score erythema 1.3, 1.7, 1.7; mean score edema 0, 0, 0). Complete reversibility was shown after 14 days at the latest.