Octabenzone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

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:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

testing of intact and abraded skin; shorter observation period, body weight not recorded.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Octabenzone

EC Number:

217-421-2

EC Name:

Octabenzone

Cas Number:

1843-05-6

Molecular formula:

C21H26O3

IUPAC Name:

[2-hydroxy-4-(octyloxy)phenyl](phenyl)methanone

Specific details on test material used for the study:

The test item was ground to a fine powder before application.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown (USA)
- Age at study initiation: ca 3 months
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: single caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, no further details
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-04-02 To: 1997-02-28

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

one side abraded, the other intact

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g onto intact skin
0.5 g onto abraded skin
(1g per animal total)

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: back
- Type of wrap if used: surgical gauze patches which secured with non-irritating adhesive tape.

REMOVAL OF TEST SUBSTANCE
Residual test article was removed from the test site by gentle wiping at the end of the exposure period, prior to scoring for dermal reactions.

OBSERVATION TIME POINTS
The wrappings were fitted with a window which was opened to examine the treated sites at 3 minutes and again at 1 hour postdose. At 4 hours the wrappings were removed and the skin reactions were scored at 24, 48 and 72 hours after patch removal.

SCORING SYSTEM:
Scoring was performed based on the Draize system. The Primary Irritation Index was calculated by adding the mean values (3 rabbits) for erythema/eschar and edema on intact and abraded skin at 24 and 72 hours (a total of 8 values) and dividing the sum by 4.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

other: A Modified Primary Irritation Index was calculated using the 24 and 72 hour scores

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: values for both intact and abraded skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: values for intact and abraded skin

Irritant / corrosive response data:

There was no erythema or edema noted at any observation period. The modified primary irritation index is 0.

Other effects:

No clinical signs were observed during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not irritating to rabbit skin in this study.

Executive summary:

In a primary dermal irritation study with rabbits the test article (0.5 g) was applied to one intact and one abraded site on the clipped back of each rabbit for a total dermal exposure dose of 1.0 g/ rabbit. In order to facilitate dermal observations during the 4 hour exposure period, the wrappings were fitted with a window which was opened to examine the treated sites at 3 minutes and again at 1 hour postdose. At 4 hours the wrappings were removed and the skin reactions were scored at 24, 48 and 72 hours after patch removal. Skin reactions were evaluated by the Draize technique. The skin was also evaluated for ulceration, necrosis, or any evidence of tissue destruction. A Modified Primary Irritation Index was calculated using the 24 and 72 hour scores.There was no erythema or edema noted at any observation period. The modified primary irritation index is 0.