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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 38, No 187, §1500 .41, p27029, 27 Sept 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Initiator 554
- Analytical purity: >98%
- Physical state: crystalline
- Storage condition of test material: protected from light

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not reported
- Weight at study initiation: mean 3.04 kg for male, 3.12 for female
- Diet: Ssniff from the company INTERMAST, ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
water
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% in water
Duration of treatment / exposure:
24 hours
Observation period:
8 days (observations at 24h, 48h, 72h, and day8)
Number of animals:
2 males and 4 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

SCORING SYSTEM: as described in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 1, fully reversible within 72 hours
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.67, fully reversible within 48 hours
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean 24-48-72 hour score for abraded application site was also 0
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 1.33, fully reversible within 8 days
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.67, also fully reversible within 48 hours
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 1, fully reversible within 72 hours
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 1.33, fully reversible within 8 days
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.67, fully reversible within 48 hours
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was also 0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of the 6 tested anmals
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
intact application site
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours in 5 animals or 8 days in one animal
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.9, also fully reversible within 72 hours in 5 animals or 8 days in 1 animal
Irritation parameter:
edema score
Remarks:
intact application site
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean 24-48-72-hour score for abraded application site was 0.4, also fully reversible within 48 hours
Other effects:
No signs of systemic toxicity observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information