Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Only 9 day observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Initiator 654
- Physical state: yellow liquid
- Expiration date of the lot/batch: Oct. 1983

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
Acclimatization period: app. 8 days
One animal per cage (stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm).
Source: Gaukler, Offenbach/Main, FRG
Weight: 2.88 - 3.12kg
Room temperature: 20 - 26°C
Humidity: conventionally (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5ml

Duration of treatment / exposure:
4 hour
Observation period:
9 days
Number of animals:
3 (1male, 2 females)
Details on study design:
Application area: 2.5 cm x 2.5 cm
Application site: Upper third of the back or flank
Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1 : 1).
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, and 9 d after the beginning of application.
Assessment according to Draize
Additional examinations: After sacrifice all animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material failed to induce dermal irritation under the conditions of the test.