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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 - 28 May 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
not specified
Deviations:
not specified
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

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: standard laboratory animal diet
- Water: 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: surgical gauze fixed to aluminum foil


REMOVAL OF TEST SUBSTANCE
- Washing: 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
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for death or overt signs of toxicity were made during exposure and the following 14-day observation period. Body weights were noted prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Erythema and Eschar Formation / Oedema Formation: After removal of the dressings and during the 14-day observation period.


Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed.
Clinical signs:
other: No signs of systemic toxicity were noted throughout the study.
Body weight:
other body weight observations
Remarks:
Body weight development was not affected by the treatment.
Gross pathology:
No abnormalities were noted.
Other findings:
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 administration of the test susbtance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute dermal LD50 of thiram was greater than 2000 mg/kg bw for both male and female rabbits.