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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-240-7
EC Name:
-
Molecular formula:
C28H42O8Cl2Co2N12Zn4
IUPAC Name:
Zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Crl:NZW/Kbl.BR
- Sex: males
- Source: Charles River Ltd., Margate, UK
- Age at study initiation: approx. 14-17 weeks
- Weight at study initiation: 2.64-3.21 kg
- Housing: singly in floor-pens with minimum floor area of 0.6 m².
- Diet and water: ad libitum
- Acclimation period: at least 27 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%): within the range 40-80%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated skin served as control.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
According to guideline, but given that no skin reactions at all were observed in the depicted study, the observation period was terminated on Day 4.
Number of animals:
3
Details on study design:
The test article was applied to a 30 x 20 mm area on the clipped and moistened (with approx. 0.1 ml distilled water) dorsum on Day I. The designated area was then covered by a dense gauze patch (30 x 20 mm). This in turn was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive bandage "Steroban" from Steroplast Ltd, Bredbury which was wrapped firmly around the torso to secure the applied dose and patch in the correct position. The dressings were considered to be semi-occlusive. The test patch was removed after four hours and the treated skin was lightly brushed clean of any solid residues and swabbed with moist cotton wool .
For reasons of animal welfare the test substance was applied to the skin of a single rabbit initially. The treated skin was assessed for a period of not less than three days to ensure the test article did not cause severe dermal changes. Subsequently, two further rabbits were similarly subjected to the testing.

Further details on study: A detailed account of any clinical signs of ill health or systemic toxicity was maintained. Each rabbit was weighed on the day before dosing commenced. The condition of all dermal test sites was recorded one hour, 24, 48 and 72 hours after removal of the patch and dressing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Other effects:
There was no indication of any adverse effect on the rabbits.

Applicant's summary and conclusion

Executive summary:

An acute dermal irritation/ corrosion study according to OECD TG 404 was performed with the test substance applied under semiocclusive dressings for 4 hours to the intact but shaved skin of a group of 3 male rabbits. No dermal reactions were observed at all after 24, 48 and 72 hours. Furthermore no indication of any adverse effect on the rabbits could be seen.