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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: 4235
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 14 weeks (males) - 15 weeks (female)
- Weight at study initiation: males 2.6 - 2.7 kg, female 2.8 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/19

IN-LIFE DATES: From: 1989-04-04 To: 1989-04-07

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: petrolatum oil (for moistening)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 cm x 10 cm
- Type of wrap if used: patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped
around the abdomen and anchored with an elastic bandage.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Other effects:
In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed during the whole observation period.

No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU