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: see 'Remark'
Remarks:
Comparable to guideline study reliable without restrictions Minor deviations from the guideline: - physical nature and batch/lot no. were not stated. - the relative humidity in the animal room should be 30 - 70 %. In this study the humidity was slightly higher (55% +/- 25 %). - approx. 24 h before the test the fur should be removed by clipping or shaving. In this study the time of removal of the fur was not stated. - the type of vehicle used for moistening the solid test substance was not clearly stated. It was only stated that either water or an appropriate fluid was used to moisten the test substance. - the age, source, and the weight of the animals at the conclusion of the test were missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 199207-17
Deviations:
yes
Remarks:
, please refer to "Rationale for reliability incl. deficiencies" above
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc iron chromite brown spinel
EC Number:
269-050-0
EC Name:
Zinc iron chromite brown spinel
Cas Number:
68186-88-9
Molecular formula:
(Zn,Fe)(Fe,Cr)2O4
IUPAC Name:
zinc iron chromite brown spinel
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): MARRÓN-B5

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2501 - 2654 grams
- Housing: individual stainless steel cages, brand Tecniplast; cleaning: automatic
- Diet (daily dose of 150 g): special diet for experimental rabbits, provided by an authorized provider
- Drink: automatic ad libitum, treated and filtered at 5 µm
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 2 °C
- Relative humidity: 55 % +/- 25 %
- Air: renewed 15 times per hour and prefiltered at 5 µm
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: water or appropriate fluid
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of a solid sample moistened with water (or appropriate fluid) was applied.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the bandages
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure and type of wrap used: the skin at the back (scapular area) close to the vertebral column was shaved (20 cm long, 13 cm wide rectangle). Once the rabbit had been shaved, the sample is applied directly onto the skin, covering a surface of approximately 6 cm^2. It was covered with a bandage, held with a plaster and covered with a hypoallergenic plaster bandage.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: once the period of exposure as ended
- Washing: the sample was softly removed with water or appropriate solvent.

SCORING SYSTEM: according to the Draize scale
Also, observations of corrosion were made (if there was a destruction of tissue in all the thickness of the skin)

OBSERVATIONS:
- Weight control: it was performed at the beginning of the study
- General examination: the general condition of the animal was observed, as well as the condition of the skin. Special attention was given to the apparition of modifications on the treated area, like corrosion, irritation, erythema, scarification, oedema or any other alteration.

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:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
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:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 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 (hardly perceptibel) was observed in all animals at the 1 hour observation.
Very slight erythema (hardly perceptibel) was observed in two animals at the 24 hour observation, which was still observed in one animal at the 48 hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
MARRÓN-B5 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.