5-(4-hydroxyphenyl)imidazolidine-2,4-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

from 15-FEB-2000 to 19-APR-2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study performed according to OECD guideline, not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-(phenylmethyl)imidazolidine-2,4-dione

EC Number:

222-563-3

EC Name:

5-(phenylmethyl)imidazolidine-2,4-dione

Cas Number:

3530-82-3

IUPAC Name:

5-benzylimidazolidine-2,4-dione

Details on test material:

- Name of test material (as cited in study report): BHT
- Molecular formula (if other than submission substance): C10H10N2O2
- Molecular weight (if other than submission substance): 190.20
- Smiles notation (if other than submission substance): N1C(N[C@@H](C1=O)Cc1ccccc1)=O
- InChl (if other than submission substance): InChI=1/C10H10N2O2/c13-9-8(11-10(14)12-9)6-7-4-2-1-3-5-7/h1-5,8H,6H2,(H2,11,12,13,14)
- Structural formula attached as image file (if other than submission substance): see Fig. attached
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: stable at least 96h in the vehicle (water)
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK, Margate, Kent, England
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: less than 3.5 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day
- Water: free access to tap-water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 30-70%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day

IN-LIFE DATES: from 15-FEB-2000 to 18-FEB-2000

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

moistened with water (Milli-U), immediately before application, to ensure close contact with the animal's skin.

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration (if solution): undiluted, moistened with water

VEHICLE
- Amount(s) applied: The test substance was moistened with 0.2 ml of the vehicle

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: the test substance was applied to the skin of one flank
- % coverage: data not available
- Type of wrap if used: a metalline patch of 2x3 cm was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was cleaned of residual test substance using water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean value (24, 48, 72 h)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean value (24, 48, 72h)

Score:

0

Max. score:

4

Irritant / corrosive response data:

Four hours exposure to 0.5 g of BHT resulted in very slight erythema in the treated skin-area of one rabbit, 1 hour after application only. No irritation was observed in the remaining two animals.

Other effects:

There was no evidence of a corrosive effect on the skin.
No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 2
60 min	0 / 1 / 0	0 / 0 / 0
24 h	0 / 0 / 0	0 / 0 / 0
48 h	0 / 0 / 0	0 / 0 / 0
72 h	0 / 0 / 0	0 / 0 / 0
Average 24h, 48h, 72h	0	0
Reversibility	yes	-
Average time for reversion	24 hours	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

BHT is not irritating to the skin in rabbits

Executive summary:

Three rabbits were exposed to 0.5 gram of BHT, applied onto clipped skin for 4 hours using a semi-occlusive dressing (OECD 404, not GLP). Observations were made 1, 24, 48 and 72 hours after exposure.

 

Exposure to the test substance resulted in very slight erythema in the treated skin-area of one rabbit, 1 hour after application only. No irritation was observed in the remaining two animals.

 

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (DSD and CLP regulation), BHT does not have to be classified and has no obligatory labelling requirement for skin irritation.