Registration Dossier
Registration Dossier
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EC number: 700-490-2 | CAS number: 36635-56-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1993 to March 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- N-[[(4-methylphenyl)sulfonyl]methyl]formamide
- EC Number:
- 700-490-2
- Cas Number:
- 36635-56-0
- Molecular formula:
- C9H11NO3S
- IUPAC Name:
- N-[[(4-methylphenyl)sulfonyl]methyl]formamide
- Details on test material:
- - Name of test material (as cited in study report): CGA 224433 tech.
- Physical state: solid
- Purity: 100%
- Lot/batch No.: P.709027
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Initial body weight range: 168 - 205g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, std soft wood bedding
- Diet (e.g. ad libitum): NAFAG 890 Tox ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12hour/day light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500, 1000 & 2000mg/kg
- Amount of vehicle (if gavage): 10ml/kg body weight - Doses:
- One single dose by gastric intubation
- No. of animals per sex per dose:
- 5 males at 1000mg/kg
15 females, 5 per dose - 500, 1000 & 2000mg/kg - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately before administration, then on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 values for females and both sexes computed using the Logit Model (J Berkson, J. Am. Stat. Ass 39 (1944), 357-365)
Results and discussion
- Mortality:
- Nine mortalities occured in this study
3 of 5 males in the 1000mg/kg bw dose group
0 of 5 females in the 500mg/kg bw dose group
1 of 5 females in the 1000mg/kg bw dose group
5 of 5 females in the 2000mg/kg bw dose group - Clinical signs:
- Piloerection, abnormal body postures and dyspnea were seen being common symptoms in acute tests.
Additionally reduced spontaneous activity was observed in the animals of all dose groups.
Ataxia was seen in females and males dosed with 1000mg/kg bw 1 to 5 days after administration.
Diarrhea was found on the males of the 1000mg/kg bw dose group 5hrs after administration. 1 male of this group was found moribund 3 to 4 days after administration before death on day 5 after administration.
Surviving animals recovered within 9 days. - Body weight:
- 165 - 205 g
- Gross pathology:
- At autopsy, a haemorrhagic thymus was detected in one male of the 1000mg/kg bw dose group and one female in the 2000mg/kg bw dose group.
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Upon an oral administration and a 14 day post treatment observation period, several mortalities occured at 1000mg/kg and greater. All surviving animals recovered from observed effects within 9 days. At necropsy, a haemorraged thymus was detected in two animals.
Therefore LD50 value set at >500mg/kg but <1000mg/kg for males, 1155 mg/kg for females, 1072 for both sexes.
Thus this substance should be assigned the hazard phrases
EU Classification - R22 harmful if swallowed
GHS Classifiaction - Oral Toxicity Category 4
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