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:
1987
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: HC:NZW
- Source: Interfauna UK Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2.8, 3.1, and 3.5 kg
- Housing: singly in wire mesh cages (Typ III) on low dust wood granulate bedding
- Diet and water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: yes, the skin areas of the contralateral flank (treated with moistened plaster) served as control
Amount / concentration applied:
500 µL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
One day prior to test substance administration the contralateral skin areas of the flanks of 3 rabbits were shorn (approx. 6x6 cm).
On the day of administration 500 µL of the test item was given on a hypoallergenic plaster (Beiersdorf No. 2342) and applied onto the skin. For negative control a further plaster was moistened with water and applied to the skin of the opposite flank. Each treatment site was then covered with elastic dressings (Fixomull-Strech Klebevlies, Beiersdorf No 2039) under semiocclusive conditions. After the 4-hours exposure period dressings and plaster were removed and the treated skin areas washed with water.
Readings were after 1, 24, 48, and 72 hours and after 7 and 14 days.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score: 1.3
Irritation parameter:
erythema score
Basis:
animal: #2, #3
Time point:
other: 24, 48, 72 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: at least 14 days
Remarks on result:
other: mean score: 1.7
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Executive summary:

Dermal irritation/corrosion of the substance was tested according to OECD TG 404 on three rabbits. In this study 500 µL of the test item was applied semiocclusively on the previously shorn skin of the flanks. The opposite areas of the skin were used for negative control (plaster moistened with water, semiocclusive dressings). Readings were after a 4 hour-exposure period according to Draize at time points 1, 24, 48, and 72 hours and after 7 and 14 days.

The substance led to slight irritant effects after 24, 48, and 72 hours (mean score erythema 1.3, 1.7, 1.7; mean score edema 0, 0, 0). Complete reversibility was shown after 14 days at the latest.