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Toxicological information

Eye irritation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.