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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
From 19 to 22 April 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid
EC Number:
200-618-2
EC Name:
Benzoic acid
Cas Number:
65-85-0
Molecular formula:
C7H6O2
IUPAC Name:
benzoic acid
Details on test material:
Batch No.: not specified
Purity: > 99.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 14 weeks
- Weight at study initiation: 2683 - 2836 g
- Housing: individually housed in a plastic cage with a perforated floor
- Diet (e.g. ad libitum): standard labortatory animal diet, 100 g per day
- Water (e.g. ad libitum): tap-water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 55 - 85%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 mL
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: approximately 10 cm x 10 cm
- % coverage:
- Type of wrap if used: test substance was applied on a Metalline patch and mounted on permeable tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test substance was removed, using a dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize score system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
ca. 0.22
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The exposure period is 4 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
ca. 0.11
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The exposure period is 4 hours.
Irritant / corrosive response data:
The test substance caused very slight erythema in two animals at 60 minutes after removel of the dressings. The erythema had resolved by day 2. Twenty-four hours after test substance removal, one animal showed very slight oedema, which resolved within 24 hours.
Other effects:
No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

Primary skin irritation scores

Observation period (hours)

Rabbit no.

4547

4549

4561

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

1

0

0

1

0

1

0

24

0

0

1

1

1

0

48

0

0

0

0

0

0

72

0

0

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 substance was considered as minimally irritating to the skin.
Executive summary:

This study was conducted according to EU Method B.4 under GLP using three New Zealand White female rabbits.

The test substance caused very slight erythema in two animals at 60 minutes after removel of the dressings. The erythema had resolved by day 2. Twenty-four hours after test substance removal, one animal showed very slight oedema, which resolved within 24 hours. No signs of systemic intoxication were observed in any of the rabbits.

The test substance was considered as minimally irritating to the skin.