Registration Dossier
Registration Dossier
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EC number: 947-984-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol
- EC Number:
- 947-984-6
- Molecular formula:
- The substance is a UVCB, of which a major component can be represented by the following: C28H46ClN3O4
- IUPAC Name:
- Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol
- Reference substance name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone, n=2
- IUPAC Name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone, n=2
- Reference substance name:
- 1,2-xylene; 1,3-xylene; 1,4-xylene; ethylbenzene
- EC Number:
- 905-588-0
- Molecular formula:
- C32H40
- IUPAC Name:
- 1,2-xylene; 1,3-xylene; 1,4-xylene; ethylbenzene
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-1-ol
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Bor:WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals, F. Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 230-298 gram (males) and 172 - 208 gram (females)
- Fasting period before study: not specified
- Housing: The rats were housed in groups of five, males and females separated in stainless steel
cages with wire-screen bottom and front.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 9 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 ºC
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: January 22, 1987 To: February 5, 1987
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10.0 mL per kg body weight (similar to 9300 mg/kg)
- Doses:
- 10.0 mL per kg body weight (similar to 9300 mg/kg)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed during the observation period
- Clinical signs:
- other: After treatment none of the test animals showed any signs of intoxication
- Other findings:
- Not performed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LC50 was found to exceed 10.0 mL per kg body weight (equivalent to 9400 mg/kg, considering a relative density of 0.94 g/cm3)
- Executive summary:
The acute oral toxicity of Ketimine resin was examined in rats. The test substance was given undiluted by gavage, in one single dose of 10.0 mL per kg body weight to 5 male and 5 female rats. After treatment none of th rats showed any sign of intoxication. No deaths occured and all rats looked quite healthy throughout the observation period. The oral LD50 of ketimine resin was found to exceed 10.0 mL per kg body weight (equivalent to 9400 mg/kg, considering a relative density of 0.94 g/cm3).
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