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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-03-18 to 1999-04-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 17th 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
January 1993
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium nitrate
EC Number:
232-218-9
EC Name:
Lithium nitrate
Cas Number:
7790-69-4
Molecular formula:
HNO3.Li
IUPAC Name:
lithium nitrate
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: Covance, Denver, PA
- Age at study initiation: young adult
- Weight at study initiation: 2.2-2.6 kg
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): Purina High FiberRabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-67
- Humidity (%): 53-54
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: test site was clipped free of fur
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 animals per sex
Details on study design:
TEST SITE
- Area of exposure: scapular to pelvic region
- Type of wrap: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Edema scores for each of the 6 animals at observation time 24, 48 or 72 hours were 0. Erythema scores for each of the animals at observation times 48 or 72 hours were 0. Only at observation time 24 hours 2 / 6 animals had an erythema score of 1 while the rest of the animals 4 / 6 had each a score of 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance lithium nitrate is not irritating to the skin of New Zealand White rabbits.
Executive summary:

An acute dermal irritation study has been performed with lithium nitrate according to OECD guideline 404 and EU method B.4. One-half gram of lithium nitrate was topically applied to 3 male and 3 female New Zealand White rabbits for 4 hours under a plastic wrap. Sixty minutes after the end of the exposure period, each test site was scored for irritation using the Draize method. Each test site was scored again 24, 48 and 72 hours after exposure. The irritation scores are as follows:

Edema scores for each of the 6 animals at observation time 24, 48 or 72 hours were 0. Erythema scores for each of the animals at observation times 48 or 72 hours were 0. Only at observation time 24 hours 2 / 6 animals had an erythema score of 1 while the rest of the animals 4 / 6 had each a score of 0.

During the first hour slight to mild erythema and slight edema were noted. At the 24-hour scoring, only slight erythema was observed on two test sites. All irritation resolved by the 48-hour scoring interval and the study was terminated following the 72-hour scoring. Based on the results of the study the test material was considered to be not irritating when topically applied to New Zealand White rabbits. (FMC, 1999)