Lithium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-20 to 1988-02-03

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Status and principle of method according OECD guideline 404 as adopted in 1981.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Lithium bromide

EC Number:

231-439-8

EC Name:

Lithium bromide

Cas Number:

7550-35-8

Molecular formula:

BrLi

IUPAC Name:

lithium bromide

Test material form:

solid: crystalline

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania, USA
- Age at study initiation: young adults
- Weight at study initiation: 3.10 - 3.31 kg
- Housing: individually in stainless steal cages
- Diet: Purina High Fiber Rabbit Chow 5326, ad libitum
- Water: fresh tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 71
- Humidity (%): 33 - 59
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: the test substance was moistened with saline

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: scapular to the pelvic region
- Type of wrap if used: cheesecloth bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: four hours

SCORING SYSTEM: Draize J. H. et al. (1944)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

2.2

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 hours

Score:

2.2

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

2

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 72 hours

Score:

2.1

Max. score:

8

Irritant / corrosive response data:

Two rabbits exhibited slight to mild erythema and slight to moderate edema over the test sites during the study. One rabbit had severe erythema, edema, eschar, exfoliation and burned areas over the sites. Irritation effects on two of the rabbits had not resolved by day 14 of the study.

Other effects:

The skin of one animal appeared to be burned.

Any other information on results incl. tables

- The following results are based on results obtained on one of the two application sites on each animal; the site where the effects were more pronounced:

Animal 1 - Erythema average score (24, 48, 72 hours): Scoring 2 (out of 4) - Not reversible in 14 days

Animal 2 - Erythema average score (24, 48, 72 hours): Scoring 0 (out of 4)

Animal 3 - Erythema average score (24, 48, 72 hours): Scoring 3 (out of 4) - Not reversible in 14 days

Animal 1 - Edema average score (24, 48, 72 hours): Scoring 1.6 (out of 4) - Reversible in 4 days

Animal 2 - Edema average score (24, 48, 72 hours): Scoring 0 (out of 4)

Animla 3 - Edema average score (24, 48, 72 hours): Scoring 2 (out of 4) - Reversible in 7 days

Animal 3 also exhibited eschar, exfoliation and test sites which appeared to be burned.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study performed with New Zealand White rabbits and under the conditions of this study, the test substance lithium bromide was regarded to be irritant to the skin.

Executive summary:

Three New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of lithium bromide anhydrous was placed in contact with each test site. The test sites were covered with gauze patches and the trunk of each animal was wrapped with a sheet of cheesecloth. The test material was in contact with the skin for 4 hours, after which the animals were unwrapped and the test material removed. Approximately 30 minutes after the end of the exposure period, the test sites were scored for irritation using the method of Draize. The test sites were scored daily thereafter for 14 days. Slight to severe erythema and slight to severe edema were noted on the test sites during the study. One rabbit also exhibited eschar, exfoliation and appeared to be burned on the test sites. Irritation on two of the rabbits had not resolved by day 14 of the study. The primary irritation index was 2.1. Under the conditions of this study and based on the Primary Irritation Index, the test material was evaluated to be irritating to intact skin when applied topically to New Zealand White rabbits. (FMC, 1988)