Registration Dossier
Registration Dossier
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EC number: 204-535-2 | CAS number: 122-34-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 November - 8 December 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Simazine
- EC Number:
- 204-535-2
- EC Name:
- Simazine
- Cas Number:
- 122-34-9
- Molecular formula:
- C7H12ClN5
- IUPAC Name:
- 6-chloro-N2,N4-diethyl-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test material: Simazine Technical
- Appearance: White powder
- Lot No.of test material: 74
- Expiration date of the batch: September 1996
- Purity: 97.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the dark at 4°C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 201 - 236 g
- Housing: Individually in metal cages with wire mesh floors
- Diet: Standard laboratory rodent diet (SDS LAD 1) available ad libitum
- Water: available ad libitum
- Acclimation period: 28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours light (0700 - 1900) : 12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 mm x 50 mm
- % coverage: ~10%
- Type of wrap if used: The treated area was covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated area was washed with warm (30°C to 40°C) water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2.88 mL/kg bw
- Concentration: 69.4% w/v in distilled water - Duration of exposure:
- 24 hours exposure
- Doses:
- 2.0 g/kg bw
- No. of animals per sex per dose:
- 5 rats/ sex
- Control animals:
- no
- Details on study design:
- Mortality: Cages of rats were checked at least twice daily.
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed twice a day for 14 days after dosing.
Dermal responses: Local dermal irritation at the treatment site was assessed daily.
Bodyweight: Individual bodyweights were recorded on Days 1 (prior to dosing), 8 and 15.
Macroscopic examination: All animals were killed on Day 15 and the macroscopic appearance of all examined tissues was recorded.
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:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- There were no signs of systemic reaction to treatment.
- Body weight:
- Slightly lower bodyweight gains were recorded for two males and four females on Day 8 with a similar trend noted for three males and one female on Day 15. All other rats achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
- Other findings:
- Dermal responses: Sites of application showed no irritation or other dermal changes throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for acute dermal toxicity to rats of Simazine Technical was found to be greater than 2000 mg/kg bw.
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