Registration Dossier
Registration Dossier
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EC number: 261-448-2 | CAS number: 58798-47-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate
- EC Number:
- 261-448-2
- EC Name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate
- Cas Number:
- 58798-47-3
- Molecular formula:
- C20H24N3O.C2H3O2 C22H27N3O3
- IUPAC Name:
- 2-[(4-methoxybenzyl)carbonohydrazonoyl]-1,3,3-trimethyl-3H-indolium acetate
- Details on test material:
- - Name of test material (as cited in study report): Basacryl Goldgelb X-GFL flüssig
- Substance type: preparation
- Physical state: liquid
- Analytical purity: 25 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA Sulzfeld
- Age at study initiation: -
- Weight at study initiation: males: 257 g; females: 196 g
- Fasting period before study: NA
- Housing: -
- Diet: Herilan MRH Kraftfutter (Eggersmann Rinteln/Weser) ad libitum
- Water: ad libitum
- Acclimation period: -
IN-LIFE DATES: From: 27. May 1981 To: 10. Jun 1981
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 cm²
- Cover: inert plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tempered water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4640, 3160, 2150, 2000, 1470, 1000, 681, 468, 400, 200, 100 mg/kg
- Concentration: 100 %, 50 %, 25 %, 5 % (unchanged, 500 mL/mL, 250 mL/mL, 50 mL/mL)
- Constant volume or concentration used: no
VEHICLE
- Concentration/Amount(s) applied (volume or weight with unit):
unchanged: 4640, 3160, 2150, 2000, 1470, 1000, 681 mg/kg
50 %: 681, 468, 400 mg/kg = 1.36, 0.94, 0.8 ml/kg
25 %: 200 mg/kg = 0.8 ml/kg
5 %: 100 mg/kg = 2 ml/kg - Duration of exposure:
- 24 hours
- Doses:
- 4640, 3160, 2150, 2000, 1470, 1000, 681, 468, 400, 200, 100 mg/kg
- No. of animals per sex per dose:
- 2150, 1470: 3
4640, 3160, 468, 400, 200, 100 mg/kg: 5
2000, 1000, 681 mg/kg: 8 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Investigations: Mortality, clinical signs, local effects
- Necropsy performed: yes - Statistics:
- -
Results and discussion
- Preliminary study:
- -
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 400 - < 1 000 mg/kg bw
- Mortality:
- Dose [mg/kg] M F
100 0/5 0/5
200 0/5 0/5
400 0/5 1/5
464 0/5 3/5
681 1/8 3/8
1000 7/8 3/8
1470 0/3 2/3
2000 3/8 8/8
2150 1/3 2/3
3160 1/5 2/5
4640 4/5 5/5 - Clinical signs:
- other: Systemic clinical signs: dyspnea, apathia, excitation, abnormal posture, ataxia, atonia, missing pain- and corneal reflex, narcosis, clonic convulsions, trembling, spastic gait, ptosis, poor general condition Local effects: skin orange discolored, minim
- Gross pathology:
- Dead animals: heart: acute dilation of anterior chamber, acute congestive hyperemia; liver: broadened lobular pattern; adrenal cortex: orange discoloration; stomach: micro-ulzerations in glandular stomach
Surviving animals: no effects
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Ther dermal LD50 in male and female rats is between 400 and 1000 mg/kg bw.
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