Chromium trichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study without deviations

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Reference 2

Reference Type:

publication

Title:

Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies

Author:

Susanne N. Kolle, Kristie M. Sullivan, Annette Mehling, Bennard van Ravenzwaay, Robert Landsiedel

Year:

2013

Bibliographic source:

Regulatory Toxicology and Pharmacology 65 (2013) 366–378

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Chromium trichloride

EC Number:

233-038-3

EC Name:

Chromium trichloride

Cas Number:

10025-73-7

Molecular formula:

Cl3Cr

IUPAC Name:

chromium trichloride

Test material form:

solid: crystalline

Details on test material:

Name of test item: Chromium trichloride
Test-item No.: 09/0625-1
Batch identification: 03207EJ
CAS No.: 10025-73-7
Purity: 32.4 % Cr
Homogeneity: The test item was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Storage conditions: Room temperature, dry storage
Physical state / color: Solid / violet
pH (undiluted test item, moistened with water): approx. 4.5

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test species / strain / quality: Rabbits / New Zealand white A 1077 INRA (SPF)
Reasons for the selection of the test species: This animal species is the worldwide accepted test system for skin irritation / corrosion studies.
Age on day 0: Ca. 5 months
Sex: Females
Supplier: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Arrival in the testing facility: Acclimatization for at least 5 days before application
Identification: Ear tattoo (by the rabbit supplier) and cage cards.
Body weight range on day 0: 3.76 kg - 4.61 kg
Room temperature / relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 °C ± 3 °C for temperature and of 30 - 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Day / night rhythm: 12 h 112 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
Enrichment: Wooden gnawing blocks (Typ KNH E-041)
Number of animals per cage: Single housing
Feeding: STANRAB (P) sac; SOS Special Diets Services, 67122 Altrip, Germany
Drinking water: Tap water ad libitum
Tap water ad libitum
Selection of animlas: Before the beginning of application, the application area was investigated for signs of pre-existing skin irritation or dense patches of hair. Only animals with intact healthy skin were used.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: untreated skin site of the same animal

Amount / concentration applied:

0.5 g, minimally moistened

Duration of treatment / exposure:

4 hours

Observation period:

72 hours and 14 days recovery period

Number of animals:

3

Details on study design:

Clipping of the fur: At least 24 hours before application clipping of the dorsolateral part of the trunk of the animal(s).
Body weight determination: Just before application of the test item and after the last reading.
Route of application: The test item was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semi occlusive" dressing. The test item was removed at the end of the exposure period with Polyethylenglycol and Polyethylenglycol / water (1 : 1).
Application volume: The test patch (2.5 cm x 2.5 cm) was covered with an amount of minimally moistened solid preparation corresponding to a dose of 0.5 g of undiluted test item.
Application site: Flanc
Negative control: Untreated skin sites of the same animal.
Readings: Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14. For details about the observation period of each animal see Table: Individual cutaneous observations and mean values in the Appendix.
Illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
Mortality: A check for any dead or moribund animal was made at least once each workday.
The evaluation of skin reactions was performed according to the quoted guidelines.
Erythema and eschar formation
Grading: 0 No erythema, 1 Very slight erythema (barely perceptible), 2 Well defined erythema, 3 Moderate to severe erythema, 4 Severe erythema (beet redness) to eschar formation preventing grading of erythema
Edema formation
Grading: 0 No edema, 1 Very slight edema (barely perceptible), 2 Slight edema (edges of area well defined by definite raising), 3 Moderate edema (raised approx. 1 mm), 4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
Descriptions of any dermal findings not covered by this scale were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No cutaneous reactions were observed during the study. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Other effects:

none observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Chromium trichloride does not show a skin irritation potential to rabbits under the test conditions chosen.

Executive summary:

The potential of Chromium trichloride to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semi occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch.

No erythema or edema was observed in all animals during the course of the study. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, Chromium trichloride does not show a skin irritation potential under the test conditions chosen.