1,4-divinylbenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

secondary source

Title:

STUDIES ON DERMAL, OCULAR AND RESPIRATORY EFFECTS OF THE TEST MATERIAL IN EXPERIMENTAL ANIMALS

Author:

RADOSŁAW ŚWIERCZ ET.AL

Year:

2000

Bibliographic source:

International Journal of Occupational Medicine and Environmental Health, 2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Dermal irritation studies were conducted on New Zealand White rabbits to assess the irritation potential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-ethyltoluene

EC Number:

210-761-2

EC Name:

4-ethyltoluene

Cas Number:

622-96-8

Molecular formula:

C9H12

IUPAC Name:

1-ethyl-4-methylbenzene

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report):4-ethyl toluene- Molecular formula :C9H12- Molecular weight:120.194 g/mol- Substance type:Organic- Physical state:LiquidPurity96%- Impurities (identity and concentrations):2-ethyltoluene approx 2.5%, 3-ethyltoluene approx 1.5%.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Animal Husbandry of The Nofer Institute of Occupational Medicine, Poland- Weight at study initiation: 3.8 + 0.2 kg body weight- Housing: cagesENVIRONMENTAL CONDITIONS- Temperature (°C): 20 —23°C- Humidity (%):45 — 60%,- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle (light on from 6 a.m. to 6 p.m.)

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: olive oil

Controls:

yes, concurrent vehicle

Amount / concentration applied:

10%, and 50% olive oil solutions (v/v), pure test chemical

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h after patch removal

Number of animals:

5 male/female rabbits

Details on study design:

TEST SITE- Area of exposure: 2.5 * 2.5 cm)- % coverage: no data- Type of wrap if used: The patches were covered with plastic foil and dressedSCORING SYSTEM: Dermal irritation index (DII) was scored according to Draize. The Draize scoring patterns for the dermal reactions observed was as follows:slightly irritating — < 2; moderately irritating — 2 — 5; and severely irritating > 5.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

10% test solution in olive oil

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

50% test solution

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

100% test chemical

Irritant / corrosive response data:

The dermal irritation index values were concentration-dependent and amounted to: 0.4, 0.8 and 1.3 for10%, 50% and 100% 4-ET solutions, respectively. Skin changes disappeared before the 7th (10%), 10th (50%) or 14th (100%) day after application

Any other information on results incl. tables

 

The dermal irritation index (DII) of rabbits exposed to the test chemical

Time observed in hours	Concentration %
	10	50	100
1	0	0	0
24	0.4	1.4	1.9
48	0.8	1.3	2.3
72	0.5	0.6	1.1
DII (average)	0.4	0.8	1.3

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The dermal irritation index values were concentration-dependent and amounted to 0.4, 0.8 and 1.3 for 10%, 50% and 100% test solutions in olive oil, respectively. Skin changes disappeared before the 7th (10%), 10th (50%) or 14th (100%) day after application.The values of the dermal irritation indices after a single exposure of rabbits indicated that the test chemical can be classified as a substance with slight irritation effect.

Executive summary:

Dermal irritation studies were conducted on New Zealand White rabbits to assess the irritation potential of the test chemical. The study was performed as per OECD 404 Guidelines. Gauze patches (2.5 * 2.5 cm) with the test chemical (0.5 cm3), its 10%, and 50% olive oil solutions (v/v), and olive oil alone (controls) were applied to the skin of 5 New Zealand White male/female rabbits for 4 hours. The exposed sites were checked for dermal irritation 1, 24, 48 and 72 h after patch removal.Dermal irritation index (DII) was scored according to Draize. The Draize scoring patterns for the dermal reactions observed was as follows:

slightly irritating — < 2; moderately irritating — 2 — 5; and severely irritating > 5.

The dermal irritation index values were concentration-dependent and amounted to 0.4, 0.8 and 1.3 for 10%, 50% and 100% test solutions in olive oil, respectively. Skin changes disappeared before the 7th (10%), 10th (50%) or 14th (100%) day after application.

The values of the dermal irritation indices after a single exposure of rabbits indicated that the test chemical can be classified as a substance with slight irritation effect.