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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiourea
EC Number:
200-543-5
EC Name:
Thiourea
Cas Number:
62-56-6
Molecular formula:
CH4N2S
IUPAC Name:
thiourea
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Young adults
- Weight at study initiation: 2.5 to 3.08 kg
- Fasting period before study: No
- Housing: Individually
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 10 % of total body area
- % coverage: 10 %
- Type of wrap if used: Thin layer of cellulose sheet wrapped in polyethylene foil

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed from the skin with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 9 mL/kg body weight
- Constant volume or concentration used: Yes (constant volume: 9 mL/kg body weight)

VEHICLE
- Amount applied: The test substance was applied as solution in water (9 mL/kg)
Duration of exposure:
24 h
Doses:
0, 1.0, 2.0 and 2.8 g/kg body weight
No. of animals per sex per dose:
2 animals per sex and dose (altogether 8 males and 8 females)
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At day 0, and at the end of week 1 and 2
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, microscopic pathology (treated skin, liver, heart, kidneys), food consumption, water intake, body weights, haematological data, autopsy, histological examination of fixed organs (heart, liver, kidney, spleen).
Statistics:
none

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 800 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: Slight erythema of the skin of rabbits treated with 2000 or 2800 mg/kg
Gross pathology:
No gross changes that could be related to the treating
Other findings:
None

Any other information on results incl. tables

Table 1: Individual body weights of male and female rabbits after a single dermal application of thiourea

















































































































































Animal number and sex



Dose g/kg



Condition of skin



Body weights (in kg)



At day 0



At the end of week 1



At the end of week 2



6336 M



0



Abraded



3.08



3.00



3.24



6338 M



0



Intact



2.80



2.83



2.93



6348 F



0



Abraded



2.83



2.82



3.00



6352 F



0



Intact



2.50



2.57



2.84



6337 M



1



Abraded



3.07



2.96



3.24



6343 M



1



Intact



2.84



2.85



2.97



6346 F



1



Abraded



2.6



2.35



2.50



6353 F



1



Intact



2.78



2.55



2.90



6340 M



2



Abraded



2.81



2.73



2.88



6341 M



2



Intact



3.05



3.04



3.12



6349 F



2



Abraded



2.66



2.68



2.94



6351 F



2



Intact



2.75



2.35



2.78



6334 M



2.8



Abraded



2.93



2.94



3.04



6339 M



2.8



Intact



2.88



2.86



3.00



6345 F



2.8



Abraded



2.70



2.60



2.91



6350 F



2.8



Intact



2.70



2.43



2.70



 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Thiourea is practically non-toxic in rabbits, when applied dermally at a single dose of up to 2.800 mg/kg.
Executive summary:

In an acute dermal toxicity study, groups of young adult New Zealand White albino rabbits (8/sex) were dermally exposed to thiourea in water for 24 hours, covering 10 % of body surface area at doses of 0, 1000, 2000 and 2800 mg/kg bw. Animals were subsequently observed for 14 days. No mortality occured at the highest dose of 2800 mg/kg bw.


Thiourea is practically non-toxic when applied in a single dose to the skin of rabbits.