Registration Dossier

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
Study period:
1997-07-15 to 1997-07-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: o-Hydroxyacetophenon

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna Ltd., Huntingdon, Cambridgeshire. England, UK
- Age at study initiation: 10 - 12 wks
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: individually in metal cages
- Diet: ad libitum, standard diet (SDS Stanrab /P) SQC Rabbit Diet)
- Water: ad libitum, tap water
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.5 - 21.5
- Humidity (%): 60 - 74
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorso lumbar region (6.25 mm²)
- Type of wrap if used: elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize et al. (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal reaction to treatment was observed in any animal throughout the study period.
Other effects:
There were no signs of toxicity observed in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information