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Toxicological information

Skin irritation / corrosion

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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:
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

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

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
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
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
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.