Chromium (III) oxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02/08/1988-09/08/1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02/08/1988-09/08/1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: during the conduct of study the stability of the test material was warrented.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 2.8 to 3.4 kg
- Housing: singly in wire cages Typ III-high
- Diet (ca. 100 to 200 g/animal/day): standard diet "ssniff K 4" (manufacturer: Ssniff Spezialdiäten GmbH, Soest/Westfalen)
- Water (ad libitum between 7 am and 7 pm): drinking water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Relative humidity: ~50%
- Air changes: 10/hrs
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test material was moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: skin area (6 x 6 cm) at the flank was shaved with an electric hair clipper the day before test item application.
- Type of wrap if used: test material moistened with water was applied to a Hansamed band-aid hypoallergen (Beiersdorf No. 2342). The treated skin area comprises about 6 cm². Another band-aid was moistened with the vehicle. The prepared band-aids were placed on the opposing flanks of each animal and fixed with an elastic adhesive bandage (Fixomull-Stretch Klebevlies, Beiersdorf No. 2039). If the experimental conditions make it necessary, another fixation with Leukoplast-porös (Beiersdorf No. 1524) was considered.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by washing with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours as well as 7 days after test item application

SCORING SYSTEM: according to Draize scale

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of dermal irritation were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to the skin.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not irritating to the skin.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chromium (III) oxide

EC Number:

215-160-9

EC Name:

Chromium (III) oxide

Cas Number:

1308-38-9

Molecular formula:

Cr2O3

IUPAC Name:

chromium (III) oxide

Test material form:

solid: particulate/powder

Details on test material:

The test material: Chromoxyd Dyko
- State of aggregation: green powder
- pH: 7 - 8

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: during the conduct of study the stability of the test material was warrented.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 3.1 to 3.4 kg
- Housing: singly in wire cages Typ III-high
- Diet (ca. 100 to 200 g/animal/day): standard diet "ssniff K 4" (manufacturer: Ssniff Spezialdiäten GmbH, Soest/Westfalen)
- Water (ad libitum between 7 am and 7 pm): drinking water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Relative humidity: ~50%
- Air changes: 10/hrs
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (equivalent to approximately 50 mg) was instilled into the conjunctival sac of one eye. The untreated eye served as control.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Duration of post- treatment incubation (in vitro):

not applicable

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were washed with physiological saline.
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize scale
Observations were recorded 1, 24, 48, and 72 hours as well as 7 days following test item application.
Furthermore, the lacrimation and the aqueous humour were examined.

TOOL USED TO ASSESS SCORE:
Corneal effects were additionally investigated using fluorescein. Furthermore, a light source was used for examination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Irritant effects were limited to Grade 1 conjunctival erythema in two animals at the one-hour observation only. All reactions had resolved by 24 hours.

Other effects:

No additional effects were observed.

Any other information on results incl. tables

Observation		1h	24h	48h	72h	Mean (24-72h)	7 days
Cornea	Opacity	0.00	0.00	0.00	0.00	0.00	0.00
Iris		0.00	0.00	0.00	0.00	0.00	0.00
Conjunctivae	Erythema	0.67	0.00	0.00	0.00	0.00	0.00
	Chemosis	0.00	0.00	0.00	0.00	0.00	0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to the eyes.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not irritating to the eyes.