Registration Dossier
Registration Dossier
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EC number: 221-493-0 | CAS number: 3119-15-1
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Remarks:
- i.p. route
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 September 1998 to 19 October 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-amino-2,4,6-triiodobenzoic acid
- EC Number:
- 221-493-0
- EC Name:
- 3-amino-2,4,6-triiodobenzoic acid
- Cas Number:
- 3119-15-1
- Molecular formula:
- C7H4I3NO2
- IUPAC Name:
- 3-amino-2,4,6-triiodobenzoic acid
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Shering Ag, Dr. Schenk, WBF, Bergkamen, Germany, Batch no: 37055008
Test animals
- Species:
- rat
- Strain:
- other: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Schering AG
- Weight at study initiation: males: 100- 116 g, females: 91-108 g
- Fasting period before study: 17.5 to 18 hours
- Housing: 1 animal per cage
- Diet (e.g. ad libitum): ad libitum 24 hours per day
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 degree C
- Humidity (%): 48 - 58%
IN-LIFE DATES:
Step 1 From:02 September 1998 To:15 September 1998
Step 2 From:09 September 1998 To: 22 September 1998
Step 3 From: 22 September 1998 To: 05 October 1998
Step 4 From: 06 October 1998 To:19 October 1998
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Remarks:
- 0.9 g NACl ad 100 ml bidist. water
- Doses:
- Step 1: 2000 mg/kg
Step 2: 2000 mg/kg
Step 3: 200 mg/kg
Step 4: 200 mg/kg
Step 5: 25 mg/kg - No. of animals per sex per dose:
- Step 1: 2000 mg/kg - 3 males
Step 2: 2000 mg/kg - 3 females
Step 3: 200 mg/kg - 3 males
Step 4: 200 mg/kg- 3 females
Step 5: 25 mg/kg- 3 females - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- One male and one female animal dies after the administration of 2000 mg of the test substance/ kg body weight. One female rat died after 200 mg of the test substance/ kg body weight. The maximum non- lethal dos of the test item after a single i.p administration was 200 mg/kg in make rats and 25 mg/kg in female rats.
- Clinical signs:
- The body weight gain observed in the animals on day 7 and on say 14 of the test was within the normal range for male and female rats of the age and strain.
The main clinical findings from 200 mg of the test item/ kg body weight onwards were apathy, disturbances in gait and ruffles fur (only observed after 200 mg/kg). In addition, prone position, disturbances in respiration, drawn – in flanks, palid skin and a decreased skin temperature were observed after administration of 200 mg of the test substance/kg mainly in male animals.
Female animals dosed with 25 mg/kg and male animals dosed 200 mg/kg showed no compound- related findings
All surviving animals were without findings from day 3 onwards. - Body weight:
- The body weight gain observed in the animals on day 7 and on say 14 of the test was within the normal range for male and female rats of the age and strain.
- Gross pathology:
- Paleness of the kidneys in one male and one female animal at 2000 mg/kg each and in one female animal at 200 mg/kg is suspected treatment related.
Applicant's summary and conclusion
- Conclusions:
- The maximum non-lethal dose of the test item after a single i.p. administration was 200 mg/kg in male rats and 25 mg/kg in female rats.The approximate LD50 of the test item after a single i.p. administration is in the magnitude of 2000 mg/kg. Paleness of the kidneys in one male and one female animal at 2000 mg/kg each and in one female animal at 200 mg/kg is suspected treatment related.
- Executive summary:
The maximum non-lethal dose of the test item after a single i.p. administration was 200 mg/kg in male rats and 25 mg/kg in female rats.The approximate LD50 of the test item after a single i.p. administration is in the magnitude of 2000 mg/kg. Paleness of the kidneys in one male and one female animal at 2000 mg/kg each and in one female animal at 200 mg/kg is suspected treatment related.
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