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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-03-18 to 1999-04-06
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 402 (Acute Dermal Toxicity)
Version / remarks:
February 24th 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
January 1993
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: young adults
- Weight at study initiation: 229-270 g
- Housing: individually housed in stainless steel, suspended cages
- Diet (e.g. ad libitum): Purina Rodent Chow 5001 (pellets), ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-69
- Humidity (%): 51-56
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: moistened with water (0.5 mL)
Details on dermal exposure:
TEST SITE
- Area of exposure: scapular to pelvic region
- Type of wrap if used: hypoallergenic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.46-0.54 g (Doses were based on individual body weights)
- Constant volume or concentration used: yes, a constant concentration was used.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
five animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs (local irritation excluded) 0.5,1,2, 3,4, and 6 hours following dosing, and daily thereafter for 14 days. Weighing was performed on days 0, 7, 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, local Irritation (was recorded on days 1, 3, 7, 14)
Statistics:
The dermal LD50 value and corresponding 95% confidence limits were calculated using a modified Logit-Linear Regression Program written by Jim Gibbons, Texas Instruments Calculator Products Division.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were noted.
Clinical signs:
All rats remained healthy during the study.
Body weight:
All rats gained weight by day 14 of the study.
Gross pathology:
No gross internal lesions were observed in any animal during necropsy.
Other findings:
Local irritation: The only irritation noted during the study was erythema on study day 1 in six animals and desquamation in four animals on day 3 and in one animal on day 7. All irritation resolved by study day 14.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the acute dermal toxicity study with lithium bromide, a LD50 greater than 2000 mg/kg in both male and female rats was derived.
Executive summary:

The acute dermal toxicity according to OECD guideline 402 and EU method B.3 was performed with lithium bromide. Lithium bromide (anhydrous) was topically applied to five Sprague-Dawley rats per sex at a dosage level of 2000 mg/kg. The test material was in contact with the skin under an occlusive wrap for 24 hours. Observations for toxicity were conducted 0.5,1, 2, 3, 4, and 6 hours post-dosing, and daily thereafter for fourteen days. Dermal irritation was recorded on days 1, 3, 7 and 14. Body weights were recorded weekly. Gross necropsies were performed on all animals. No deaths were noted. All rats remained healthy and gained weight by day 14 of the study. The only irritation noted during the study was erythema on study day 1 in six animals and desquamation in four animals on day 3 and in one animal on day 7. All irritation resolved by study day 14. No gross lesions were revealed during necropsy. The LD50 is greater than 2000 mg/kg in both male and female rats when topically applied. (FMC, 1999)