Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 400-600-6 | CAS number: 71868-10-5 ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- prior to GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
- EC Number:
- 400-600-6
- EC Name:
- 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
- Cas Number:
- 71868-10-5
- Molecular formula:
- C15 H21 N O2 S
- IUPAC Name:
- 2-methyl-1-[4-(methylsulfanyl)phenyl]-2-(morpholin-4-yl)propan-1-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 159 - 215 g
- Fasting period before study: overnight
- Housing: groups of 5
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), provided ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 55+/- 15
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight
- Doses:
- 1000, 2000, 4000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations and weighing: Mortality = daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and Symptoms = daily; Body weight = on days 1, 7, 14, 28 and at death
- Necropsy of survivors performed: yes, Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 756 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 340 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: estimated value
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 984 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: average value of both sexes
- Mortality:
- males:
1000 mg/kg/bw: 0/5 animals died
2000 mg/kg/bw: 1/5 animals died
4000 mg/kg/bw: 4/5 animals died
females:
1000 mg/kg/bw: 2/5 animals died
2000 mg/kg/bw: 3/5 animals died
4000 mg/kg/bw: 5/5 animals died - Clinical signs:
- other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition sedation, lateral and ventral body position, chromodacryorrhea, diarrhea, tonic clonic convulsions and bilateral paresis of the hindl
- Gross pathology:
- Besides two cases of spotted lung in the high dose group no findings were made at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test material to male and female rats was determined to be 1984 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
