Iron cobalt chromite black spinel

Endpoint summary

Description of key information

Skin irritation: not irritating (equivalent or similar to OECD 404; Non-GLP compliant)
Eye irritation: not irritating (equivalent or similar to OECD 405; Non-GLP compliant)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

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.

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.

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:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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: - the relative humidity was slightly higher than 70 % (55 % +/- 25%). - it was not stated, if the eyelids were held together after application of the test substance. - age, source and the weight at the conclusion of the test of the animals was not given. - the opacity of the cornea was not recorded at the 1 hour observation

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

yes

Remarks:

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

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2675 grams - 2803 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

At arrival at the Unit, rabbits went through a health control.

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.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the solid test item (grinded to fine dust) was administered into the conjunctival bag of one eye by separating the lower eyelid.The untreated eye was used as control.
No further information on the amount/concentration applied was stated.

Observation period (in vivo):

1, 24, 48 and 72 hours after administration of the test substance
(the opacity of the cornea was not recorded at the 1 hour observation)

Number of animals or in vitro replicates:

3 males

Details on study design:

The rabbits were fixed in an immobilization trap during test item administration.

REMOVAL OF TEST SUBSTANCE
not stated

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: in order to facilitate the evaluation of the reactions, light from a manual lamp was used and 24 hours after administration of the test item, fluorescein was used to check for injuries of the cornea.

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 conditions of the eyes. Special attention was given to the apparition of modifications on the treated eye: cornea, iris, conjunctiva, as well as any other injury observed.
No further information on the study design was stated.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 adn 72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 adn 72 hours

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 adn 72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Erythema of the conjunctiva of grade 2 observed in one animal at the 1 hour observation and erythema of the conjunctiva of grade 1 was observed in the remaining animals at the 1 hour observation.
Oedema of the conjunctiva of grade 1 was observed in all animals was observed at the 1 hour observation.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

SÓLIDO is not irritating to the eye.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

One reliable in vivo study described by Alvarez Genoher (2003) (equivalent or similar to OECD 404; Non-GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the skin.

Eye irritation

One reliable in vivo study described by Alvarez Genoher (2003) (equivalent or similar to OECD 405; Non-GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
One reliable in vivo study described by Alvarez Genoher (2003) (equivalent or similar to OECD 404; Non-GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the skin.

Justification for selection of eye irritation endpoint:
One reliable in vivo study described by Alvarez Genoher (2003) (equivalent or similar to OECD 405; Non-GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the eyes.

Justification for classification or non-classification

Skin irritation

Reference Alvarez Genoher (2003) is considered as the key study for in vivo skin irritation and will be used for classification. The skin irritation was scored according to the Draize scale. The mean score (24, 48, 72h) for erythema and oedema was 0 for all animals. The study was terminated after the 72 hour observation. According toregulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as skin irritant.

Eye irritation

Reference Alvarez Genoher (2003) is considered as the key study for in vivo eye irritation and will be used for classification. During the study the test item was applied to one eye of three animals each and the eye irritation was scored according to the Draize scale.The corneae and irises were not affected by instillation of the test item. In three animals a conjunctivae score (redness) of 0.33, 0.67 and 0.67 was observed, respectively. The conjunctival effect was fully reversible within 72 hours. Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes.

Respiratory irritation

The classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.