Registration Dossier
Registration Dossier
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EC number: 202-605-7 | CAS number: 97-74-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- publication
- Title:
- Acute Toxicologic evaluation of Tetramethyl thiuram monosulfide
- Author:
- Bombard E., Löser E.
- Year:
- 1 996
- Bibliographic source:
- J.Am.Coll.Toxicol., Vol 15, Suppl.1
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- duration of observation after exposure : 8 days (and not 14 days).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- tetramethylthiuram monosulfide
- IUPAC Name:
- tetramethylthiuram monosulfide
- Reference substance name:
- Tetramethylthiuram monosulphide
- EC Number:
- 202-605-7
- EC Name:
- Tetramethylthiuram monosulphide
- Cas Number:
- 97-74-5
- Molecular formula:
- C6H12N2S3
- IUPAC Name:
- N,N-dimethyl[(dimethylcarbamothioyl)sulfanyl]carbothioamide
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W.Ostrop/Meerbusch
- Age at study initiation: no data
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24-48-72 hours, 8 days
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no details
- Type of wrap if used: Double layers of surgical gases
REMOVAL OF TEST SUBSTANCE: no
SCORING SYSTEM: as Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 rabbits with intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 rabbits with intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- A very sight erythema was observed in one rabbit at 24 hours after exposure to the test article.
Slight oedemas were observed in rabbit at 24 and 72 hours, and this effect was not reversible at 8 days. - Other effects:
- no
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not skin irritating
- Conclusions:
- According to this study, tetramethylthiuram monosulfide (TMTM) is slightly irritating for skin in rabbits but not classified based on CLP criteria.
- Executive summary:
The potential of the test substance tetramethylthiuram monosulfide to induce skin irritation was evaluated in rabbits.
The test substance was applied for periods of 24 hours to a six New Zealand White rabbits. A single dose of 500 mg of the test substance with water was applied to the closelyclipped skin of one flank.
Slight cutaneous reactions (erythema and edema) were observed during the study: the mean erythema score for the 6 rabbits is 0.1/4 (mean 24/72h) and the mean oedema score is 0.83/4 (mean 24/72h). Erythema was fully reversible in 72 hours but oedema was not fully reversible in 8 days.
Under these experimental conditions, the test substance tetramethylthiuram monosulfide is slightly irritating when applied topically to rabbits but not classified based on CLP criteria.
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