Registration Dossier
Registration Dossier
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EC number: 425-950-7 | CAS number: 187393-00-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Holding Company Ltd.; 4414 Füllinsdorf, Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): CFG-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 002
- Expiration date of the lot/batch: 31 Aug 1998
- Stability under test conditions: stable in PEG 400 for at least 48 hours
- Storage condition of test material: in the original container at room temperature away from direct sunlight
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, 4414 Fullinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks; Females: 11 weeks- Fasting period before study: 16 hours
- Weight at study initiation: Males: 231.7 - 256.9 g; Females: 190.4 - 219.8 g
- Housing: Groups of five in Makrolon type -4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch nos 81/96 and 84/97 rat maintenance diet available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itengen, available ad libitum
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees centigrade
- Humidity (%): 40 - 70%
- Air changes (per hr):10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- (PEG 400)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs
- % coverage: 10
- Type of wrap if used: elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 24 hrs
TEST SOLUTION
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw
- Concentration of test material: 0.5 g/ml
- Dose: 2000 mg/kg bw
- For solids, paste formed: no (suspension in PG400) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily, with weighings on days 1 (prior to exposure), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None, as no deaths ocurred.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No abnormalities
Any other information on results incl. tables
Group / Sex |
Animal |
Day 1 |
Day 8 |
Day 15 |
1 / Males (2000 mg/kg bw) |
1 |
245.8 |
271.9 |
299.9 |
2 |
243.4 |
265.0 |
299.1 |
|
3 |
256.9 |
284.0 |
320.2 |
|
4 |
242.5 |
272.9 |
306.1 |
|
5 |
231.7 |
266.5 |
300.1 |
|
Mean |
244.1 |
272.1 |
305.1 |
|
+S.D. |
9.0 |
7.5 |
8.9 |
|
N |
5 |
5 |
5 |
|
1 / Females (2000 mg/kg bw) |
6 |
209.4 |
211.0 |
220.7 |
7 |
206.4 |
207.5 |
214.5 |
|
8 |
219.8 |
225.5 |
229.0 |
|
9 |
219.5 |
227.5 |
237.8 |
|
10 |
190.4 |
204.4 |
212.6 |
|
Mean |
209.1 |
215.2 |
222.9 |
|
+S.D. |
12.0 |
10.6 |
10.5 |
|
N |
5 |
5 |
5 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- No mortality, clinical signs of toxicity, or macroscopic abnormalities were observed at the dermally applied limit dose of 2000 mg/kg bw.
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