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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.05.85-28.05.85
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
room temperature was twice increased for 12-14 hours above 20 2°C, due to a technical failure. This deviation was considered not to has affected the outcome of the study.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiram
EC Number:
205-286-2
EC Name:
Thiram
Cas Number:
137-26-8
Molecular formula:
C6H12N2S4
IUPAC Name:
thiram
Details on test material:
- Name of test material (as cited in study report): TMTD technical
- Physical state: powder
- Analytical purity: 98.8 %
- Impurities (identity and concentrations): water 0.15 %, sodium sulfate 0.35 %, tetramethylthiurammonosulfide 0.21 %, borrebond normal 0.60 % and sodium dodecylbenzenesulfonate 0.10 %
- Stability under test conditions: active ingredient very stable after 14 days storage at 55 °C. Aqueous suspension is very stable at pH 6-7.
- Storage condition of test material: at ambient temperature in the dark
- Melting point: ~ 140 °C
-Specific gravity: ~ 0.3
- Lot/batch No.: P53/02-85

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: 18 weeks (male and female)
- Weight at study initiation: 2.7-2.9 kg (male), 2.8-3.0 kg (female)
- Housing: induvidually housed in metal cages
- Diet (e.g. ad libitum): standard laboratory animal diet
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 13 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-27
- Humidity (%): 60-85
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: mid-dorsal area
- % coverage: 10 (body surface)
- Type of wrap if used: surgical gauze fixed to aluminum foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with a wet paper tissue
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Clinical signs:
No deaths and no signs of systemic toxicity were noted throughout the study. In the beginning of the study the treated skin surface generally showed slight erythema. Some areas revealed well-defined and moderate erythema. These signs were resolved one week after treatment. There were no signs of dermal irritation at the end of the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted.

Applicant's summary and conclusion