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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-01-21 to 1988-01-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium carbonate
EC Number:
209-062-5
EC Name:
Lithium carbonate
Cas Number:
554-13-2
Molecular formula:
CH2O3.2Li
IUPAC Name:
dilithium carbonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: Lithium carbonate, Technical Grade
- Physical state: White solid
- Analytical purity: 99 %

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
- Age at study initiation: Young adult
- Weight at study initiation: 3.19 kg to 3.33 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum, Purina High Fiber Rabbit Chow 5326
- Water (e.g. ad libitum):ad libitum, fresh tap water


ENVIRONMENTAL CONDITIONS
- Temperature (degree C): 20 - 21.7 °C
- Humidity (%): 36 - 48
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
The animals were weighed once on the day before dosing. Clinical signs were recorded as noted. Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of Draize.
Number of animals:
3 (2 male, 1 female)
Details on study design:
TEST SITE
- Area of exposure: The clipped area extended from the scapular to the pelvic region. One test site was located on each side of the spinal column.
- Type of wrap if used: semi-occlusive cheesecloth bandage


REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: exposure-time: 4 hours


SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of Draize. The sites were evaluated daily thereafter for 5 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All animals remained healthy throughout the study.
One rabbit had slight erythema on study days 1 - 4. All irritation had resolved by study day 5 which time the test was terminated.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study , the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours.
Executive summary:

An acute skin irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 404. 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 carbonate Technical Grade 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, 24, 48, 72 hours after the end of the exposure period, the test sites were scored for irritation using the method of Draize. Irritation observed in one of the three animals (scored 1 for erythema) had resolved by the end of the study (day 5). Under the conditions of this study, the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours. The used scores of the test system (US scheme) were adapted to the EU scheme. Thus, based on the results obtained lithium carbonate has not to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP).

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