Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-04-11 to 1985-04-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted under GLP conditions according to the official OECD guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl benzoate
EC Number:
202-259-7
EC Name:
Methyl benzoate
Cas Number:
93-58-3
Molecular formula:
C8H8O2
IUPAC Name:
methyl benzoate
Details on test material:
- Physical state: colourless liquid
- Storage condition of test material: stored at ambient temperature in brown glass screw-top bottle

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.24 to 2.66 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet, AW Tindall Limited, Holbeach, Lincolnshire ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least five days prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 51 to 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 11 April 1985 To: 14 April 1985

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of the neat test material was applied onto the skin
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
three
Details on study design:
TEST SITE
- Area of exposure: test substance was applied onto a test site on the back of each rabbit
- % coverage: substance was evenly distributed onto a patch (surgical gauze) with a surface area of 6.25 cm2
- Type of wrap if used: sleek adhesive strapping

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in ether
- Time after start of exposure: 4 hours after exposure

SCORING SYSTEM: Scoring was done according to the scale developed by Draize JH 1959, Association of Food and Drug Officials of the United States, Austin, Texas: The appraisal of the safety of chemicals in foods, drugs and cosmetics.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after application
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after application
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test material produced no evidence of primary cutaneous irritation in any rabbit throughout the observation period of 72 hours. Desquamation extending beyond the site of application was observed in all three rabbits at the 72 hours reading only.
Other effects:
No other effects were reported.

Any other information on results incl. tables

Table 1: Individual erythema and oedema scores

 

 

Individual scores (according to Draize)

 

Skin reaction

Reading (hours)

Rabbit 1 (417)

Rabbit 2 (427)

Rabbit 3 (459)

Total

Erythema and Eschar formation

1

0

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Oedema formation

1

0

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found to be non-irritant to rabbit skin.
Executive summary:

The skin irritation potential of the test substance methyl benzoate was studied under GLP condition in an in-vivo rabbit study according to OECD guideline No 404. The backs and the flanks of three healthy albino rabbits of the New Zealand White strain (aged 12 to 16 weeks and weighing between 2.2 and 2.6 kg) were clipped off the fur the day prior to the start of the test. On the day of the test, an aliquot of 0.5 mL of the neat test substance was applied onto the undamaged skin of the animals. To this end, the test material was distributed evenly onto a semi-occlusive patch with a surface area of 6.25 cm2, which was then fixed on the skin with adhesive strapping. The patch was removed after four hours of exposure and remaining test substance was removed by gentle swabbing with cotton wool soaked in ether. The skin reaction was graded in accordance with the scoring system developed by Draize (1959). The test material produced no evidence of primary cutaneous skin irritation in any rabbit throughout the observation period of 72 hours and the individual scores for erythema and oedema were "zero" at observation time points 24, 48 and 72 hours after treatment. Desquamation extending beyond the exposure site was observed in all three animals at the 72 hours reading only. On the basis of the test results it was concluded that methyl benzoate is non-irritant to the rabbit skin.