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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 404 and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzylalkohol
- Purity: 99.99%
- Appearance: colourless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: albino rabbits, HC:NZW
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England, UK
- Age at study initiation: adult rabbits
- Weight at study initiation: 3.1-3.4 kg
- Housing: individually under standardized conventional conditions in stainless steel cages with perforated floors
- Diet: approx. 100-120 g/animal and day; feeding once per day in the morning
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite dorsal area of the trunk of each animal served as control
Amount / concentration applied:
500 µl (ca. 522 µg)
Duration of treatment / exposure:
4 hours
Observation period:
7 days (all changes had completely subsided after 7 days)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorso-lateral area of the trunk, 6x6 cm
The test compound was applied to a hypoallergenic patch and a further patch was moistened with water for control; they were loosely held in contact with skin by means of a semiocclusive dressing for the exposure period

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully with water
- Time after start of exposure: 4 h

SCORING SYSTEM:
The degrees of erythema/eschar formation and oedma formation was recorded as specified by Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
see data above
Other effects:
no further data

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Executive summary:

In a study for skin irritation/corrosion on rabbits according to OECD TG 404 benzyl alcohol showed only slight effects to the skin in one animal (exposure period: 4 hours, 2 rabbits without any irritant effects, 1 rabbit with erythema score 1 at maximum, fully resolved within 72 hours) (Bayer AG 1990).