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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
Study period:
05.07.1988 - 29.08.1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Physical state: greyish-green powder
- Analytical purity: 100%
- Lot/batch No.: 3883559 A
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals Inc., Denver, Pennsylvania.
- Age at study initiation: young adults (at least 8 weeks old)
- Weight at study initiation: no data
- Housing: individually
- Diet: Lab Rabbit Chow HF (Purina #5326), 125 g/day while on test.
- Water: tap water, ad libitum.
- Acclimation period: 55 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped
Vehicle:
physiological saline
Controls:
other: untreated skin of the same animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.5 grams

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
6 (2 males, 4 females).
Details on study design:
TEST SITE
- Type of wrap if used: gauze and porous tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess test material was removed using dry gauze.
- Time after start of exposure: 4 h

SCORING SYSTEM: draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h - 48 - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Erythema findings: right front/left front:

 Time  animal 1  animal 2  animal 3  animal 4  animal 5 animal 6
 0,5 h  1/0 0/1   0/0  0/1  0/0  0/0
 24 h  0/1  0/0  0/0  0/1  0/0  0/0
 48 h  1/1  0/0  0/0  0/1  0/0  0/0
 72 h  0/0  0/0  0/0  0/0  0/0  0/0

Edema findings: right front/left front:

 Time  animal 1  animal 2  animal 3  animal 4  animal 5 animal 6
 0,5 h  0/0   0/0  0/0    0/0   0/0   0/0
 24 h   0/0   0/0   0/0   0/0   0/0  0/0
 48 h   0/0   0/0   0/0   0/0  0/0   0/0
 72 h   0/0   0/0   0/0  0/0   0/0   0/0

The test substance produced only mild to transient dermal irritation. The only irritation seen was slight (barely perceptible) erythema in three of the six animals, which subsided within one to three days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information