Isobutyrophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Feb. 12, 1990 to Jul. 20, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant and guideline conform

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyrophenone

EC Number:

210-275-0

EC Name:

Isobutyrophenone

Cas Number:

611-70-1

Molecular formula:

C10H12O

IUPAC Name:

2-methyl-1-phenylpropan-1-one

Details on test material:

- Name of test material (as cited in study report): Darocur 1173, stage 1
- Physical state: Liquid
- Lot/batch No.: Beleg 281

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 20 - 21 weeks
- Weight at study initiation: 2.80 to 3.24 kg (mean weight of 3.08 kg)
- Housing: Housed separately in cages type KK 017
- Diet (e.g. ad libitum): Altromin standard diet TPF 2113, pellets ad libitum
- Water (e.g. ad libitum): acidified, fully demineralized water, ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 26
- Humidity (%): 41 to 58
- Photoperiod (hrs dark / hrs light): not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Area of exposure: left and right intact side of the animals' backs
- % coverage: 4 cm squared
- Type of wrap if used: The application site was wrapped with polyethylene foil, which was kept in place by a leather sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none (any test material left after patches were removed, was wiped off)
- Time after start of exposure: after 4 hours of occlusive exposure the patches were removed

SCORING SYSTEM: Same scale as the one provided in the OECD guideline 404.
Other observations reported (in addition to OECD parameters): S = scales; GS = large scales

The rabbits were investigated for skin alterations, behavior, and general condition 1 hour after removal of the patches, and then daily for a period of further 14 days. All rabbits were weighed before start of the study and on days 5, 8, 11, and 15. Skin changes at the application site were evaluated according to the DRAIZE ("Dermal Toxicity", In.: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Association of Food and Drug Officials of the USA, 1959) and OECD recommendations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

for left and right back site

Basis:

mean

Time point:

other: Day 1 (1 hour)

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: Refer to attached table 1 for full details

Results 2

Irritation parameter:

edema score

Remarks:

for left and right back site

Basis:

mean

Time point:

other: Day 1 (1 hour)

Score:

0

Max. score:

8

Remarks on result:

other: Refer to attached table 1 for full details

Irritant / corrosive response data:

Erythema (value 1) was observed in all rabbits 1 hour after removal of the patches. No edema occurred and no other signs of primary skin irritation according to the OECD rating occurred. From day 4 until day 14 of the study, scales and large scales were observed in 2 of the 3 rabbits (See table 1 for full details).

Other effects:

No signs of systemic toxicity were detected. The body weight development corresponded to that of untreated rabbits of the same age. All rabbits survived the 15 day observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU