1,4-divinylbenzene

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Ocular irritation studies were conducted on Chinchilla 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 / tissue source

Species:

rabbit

Strain:

Chinchilla

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Animal Husbandry of The Nofer Institute of Occupational Medicine, Poland- Weight at study initiation: 4.0 + 0.1 kg body weight- Housing: stainless steel 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 cm3

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

1, 24, 48 and 72 h after dosing

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3

Details on study design:

Details on study designTEST SITE- Area of exposure: conjunctival sacSCORING SYSTEM:The ocular reactions were observed and scored according to the Draize. The eye irritation ratings were: no reaction — 0; slightly irritating — 1 — 16; moderately irritating — 17 — 35; severely irritating — 36 — 75; and extremely irritating - 7 5 - 110

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

110

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Eye changes were minimal, and they were observed no longer than 6 days after application. The Eye Irritation Index was calculated to be 1.7.

Any other information on results incl. tables

The eye irritation index (EII) of rabbits exposed to the test chemical

Time observed in hours	EII
1	2.1
24	1.8
48	2.0
72	0.8
EII ()Average)	1.7

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Eye changes were minimal, and they were observed no longer than 6 days after application. The Eye Irritation Index was calculated to be 1.7.The eye irritation indices after a single exposure of rabbits indicated that the test chemical was a substance with slight irritation effects.

Executive summary:

Ocular irritation studies were conducted on Chinchilla rabbits to assess the irritation potential of the test chemical. The study was performed as per OECD 405 Guidelines.0.1 cm3 of the test chemical was instilled in the conjunctival sac of a defect-free eye of 3 rabbits. The other eye remained untreated and served as control.The ocular reactions were observed and scored according to the Draize at 1, 24, 48 and 72 hours after dosing.

The eye irritation ratings were: no reaction — 0; slightly irritating — 1 — 16; moderately irritating — 17 — 35; severely irritating — 36 — 75; and extremely irritating - 7 5 – 110.

Eye changes were minimal, and they were observed no longer than 6 days after application. The Eye Irritation Index was calculated to be 1.7.

The eye irritation indices after a single exposure of rabbits indicated that the test chemical was a substance with slight irritation effects.