Iron cobalt chromite black spinel

Skin irritation / corrosion

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 was not stated. - approx. 24 h before the test the fur should be removed by clipping or shaving. In this study it was not stated at which point in the study the fur was removed. - the relative humidity in the animal room should be 30 - 70 %. In this study the humidity was slightly higher (55% +/- 25 %). - 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, the 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:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2002-04-24

Deviations:

yes

Remarks:

, please refer to "Rationale for reliability incl. deficiencies" above

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Iron cobalt chromite black spinel

EC Number:

269-060-5

EC Name:

Iron cobalt chromite black spinel

Cas Number:

68186-97-0

Molecular formula:

(Co, Fe)(Fe,Cr)2O4

IUPAC Name:

dichromium(3+) diiron(3+) λ²-cobalt(2+) λ²-iron(2+) octaoxidandiide

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): SÓLIDO
No further information on the test material was stated.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2345 - 2506 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
No further information on the test animals was stated.

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.
No further information on the amount/concentration applied was stated.

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.
No further information on the study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 6

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 (hardly perceptible) erythema was observed in all rabbits at the 1 hour observation.
No erythema or oedema was observed at the 24, 48 and 72 hour observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

SÓLIDO 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.