Calcium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium bromide

EC Number:

232-164-6

EC Name:

Calcium bromide

Cas Number:

7789-41-5

Molecular formula:

CaBr2

IUPAC Name:

calcium bromide

Details on test material:

White powder, stored at room temperature over silica gel.
For the purpose of this study the test material was used as supplied.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were individually housed in a suspended metal cages. Free access to mains drinking water and food was allowed throughout the study. The animal room was maintained at a temperature of 17-21C and relative humidity of 56-65%. The rate of air exchange was approximately 15 changes per hour and the lightning was controlled by a time switch to give 12 hours light and 12 hours darkness.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped using veterinary clippers

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of calcium bromide moistened in 0.5ml of water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours and 7 days

Number of animals:

3

Details on study design:

No further details

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

2.5

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24h

Score:

2

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 48h

Score:

2

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72h

Score:

2

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24h

Score:

2

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 48 h

Score:

1

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 72h

Score:

1

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24h

Score:

1

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 48h

Score:

0

Results 10

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72h

Score:

0

Results 11

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24h

Score:

1

Results 12

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 48h

Score:

0

Results 13

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 72h

Score:

0

Results 14

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24h

Score:

2

Results 15

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 48h

Score:

1

Results 16

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 72h

Score:

1

Results 17

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24h

Score:

2

Results 18

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 48h

Score:

1

Results 19

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 72h

Score:

1

Irritant / corrosive response data:

Very slight to well-defined erythema was noted at all treated skin sites 1 hour after patch removal and at the 24h observation. Very slight or well-defined erythema was also noted at two treated skin sites at the 48 and 720hour observations.
Slight oedema was noted at all treated skin sites 1 hour after patch removal with very slight to slight oedema at the 24-hour observation. Very slight oedema persisted at two treated skin sites at the r48 and 72-hours observations.
Crust formation was confined to one treated skin site at the 7-day observation. This was considered to be reversible reaction.
A small area of possible dermal necrosis was noted along the edge of two treatment sites and developed into a hardened dark brown-coloured scab. This reaction was considered to have been caused by the surgical adhesive tape in contact with the test material.

Other effects:

No further details

Any other information on results incl. tables

No further details

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, calcium bromide, produced a primary irritation index of 2.5 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labeling regulations. No symbol and risk phrase are required.