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Registration Dossier
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EC number: 202-607-8 | CAS number: 97-77-8
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 25.03.-13.08.1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance tetramethylthiuram disulfide (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance. (For detailed information on the justification of read-across, please refer to the analogue justification document attached in IUCLID section 13).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Thiram
- EC Number:
- 205-286-2
- EC Name:
- Thiram
- Cas Number:
- 137-26-8
- Molecular formula:
- C6H12N2S4
- IUPAC Name:
- tetramethylthiuram disulfide
- Details on test material:
- - Name of test material (as cited in study report): Thiram
- Physical state: cramy white powder
- Analytical purity: 99 %
- Purity test date: 20.02.1994
- Lot/batch No.: V614/0801 AC
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in non-continuous artificial light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 6 h/d for 21 (males) or 22 (females) consecutive days
- Frequency of treatment:
- 21 (males) or 22 (females) consecutive days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg and day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects
- Dose descriptor:
- NOEL
- Effect level:
- < 100 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: dermal irritation
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Clinical signs:No treatment-related changes were observed.
Mortality: No deaths.
Local dermal irritation: Control group: no dermal signs. All treatment groups: slight or well-defined erythema with or without slight or well-defined oedema, with well-defined responses noted with greater frequency in the mid- and high-dose group. Reactions were observed initially in isolated incidences on Day 7 but over the following two weeks developed in the great majority of rabbits. These reactions were frequently accompanied by residual (brown) staining from the test substance and/or desquamation of the stratum corneum.
Bodyweight gain: Reduced bodyweight gain was observed in females dosed at 1000 mg/kg bw/day.
Food consumption: Reduction in mean food consumption was measured for females dosed at 1000 mg/kg bw/day throughout the study. These changes were statistically significant (p 0.05) in week 1 and 2.
Blood analysis: Haematology: No treatment-related changes. Clinical chemistry: Liver enzymes GOT, GPT, and cholesterol levels were increased in females dosed at 1000 mg/kg bw/day. Alkaline phosphatase activity was increased at 1000 mg/kg bw/day in both sexes.
Sacrifice and pathology: Organ weights: No dose-related effects.
Gross and histopathology: Gross pathology: no treatment-related effect.
Histopathology: Minimal generalised/focal acanthosis of epidermis at the treated skin sites of all male and female rabbits were considered treatment-related.Applicant's summary and conclusion
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