Registration Dossier

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 reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
Deviations:
yes
Remarks:
fur clipped at least 15 h before test begin; examination for erythema & oedema at 30 - 60 min. after test patch removal & 24 h, 48 h, 72 h after the beginning of application; modified Draize scoring system; reading skin reaction at 30 - 60 min. missing.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Sicocer F Eisenrosa 2320
- Physical state: powder, pink
- Storage condition of test material: room temperature
- Homogeneity: the sample appeared to be homogenous

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.62 - 2.87 kg
- Housing: cage made of stainless steel with wire mesh walk floors; floor area: 40 cm x 51 cm; no bedding in the cages; sawdust in the waste trays; rabbits were housed singly
- Diet (about 130 g per animal per day): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (about 250 mL per animal per day): tap water
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS - animals were housed in fully air-conditioned rooms.
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 minutes after removal of the test patches and 24, 48 and 72 hours after the beginning of the application
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: at least 15 hours before the beginning of the study the upper third of the back or flanks were clipped. The application area was 2.5 cm x 2.5 cm. The test patch (2.5 cm x 2.5 cm) was covered with a dose of the unchanged test substance and has been moistened with aqua bidest.. Because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible.
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: at the end of the exposure period
- Washing: with lutrol and lutrol/water (1:1)

SCORING SYSTEM: according to a modified Draize scale.
Evaluation of erythema and oedema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe

OBSERVATIONS:
Shortly before application of the test substance the weight of the rabbits was determined. Symptoms were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
anmimal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed in all animals at a 4 hour observation.
Very slight erythema was observed in one animal at the 24 hour observation.
No erythema or oedema was observed in two animals at the 24, 48 and 72 hour observations.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sicocer F Eisenrosa 2320 is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.