Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP and Pre OECD study. Observation limited to 24 hours and 72 hours after treatement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24h application and only 24 and 72h observation.
Principles of method if other than guideline:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: off white waxy solid
Details on test material:
Name TK 12146
ZK 502
3942
Batch : Op1/76 K-650

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The rabbits were caged singly in an experimental room maintained at a temperature of 2D°C. (± 1°) and a relatiue humidity of 50-70%. Animals uere exposed to artificial light for 10 hours daily frorn 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was evailable at all times.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Abraded skin/Intact skin
Vehicle:
other: 50% PEG
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): 50%
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure:2.5 cm2
- Type of wrap if used: aluminium foil secured uith "Sleek"* adhesive taps. Ths test sites uere then couered by a 6" uide "Coban"** self adhesive bandage in order to retain the test substance in close contace uith the skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No


SCORING SYSTEM:
Erythema and Eschar Formation
Description Grads
No erythema O
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4

Oedema Formation
Description Grade
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm.) 3
Seuere-oedema (raised more than 1 mm. and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours aboservations
Score:
0.21
Reversibility:
fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not considered to be irritant to the skin.
Executive summary:

Six rabbits (3 males and 3 females) were treated during 24 hours under occlusive dressing with 1.0 mL of the substances solution (mixed with a 50% aqueous solution of PEG).

After 24 hours slight erythema uas seen on l/6(intact and abraded sites and very slight oedema on 1/6 intact and 2/6 abraded sites.

After 72 hours, all sites were normal.

Generally, there was no differences-seen in the reactions between intact and abraded sites.

The primary irritation score was 0.2.