Registration Dossier
Registration Dossier
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EC number: 282-162-4 | CAS number: 84100-84-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-09-12 to 1988-10-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Official Journal L 251 , 19/09/1984 P. 96
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD 401, adopted 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Deviations: no quality assurance implemented for conduct and reporting of test; no analytical test on stability of test substance due to short period between preparation and dosage; deviations do not have an impact on the testing results.
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,3,3-trimethyl-3H-indole-5-carboxylic acid
- EC Number:
- 282-162-4
- EC Name:
- 2,3,3-trimethyl-3H-indole-5-carboxylic acid
- Cas Number:
- 84100-84-5
- Molecular formula:
- C12H13NO2
- IUPAC Name:
- 2,3,3-trimethyl-3H-indole-5-carboxylic acid
- Test material form:
- other: Moist presscake, white-faint reddish
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMA
- Source: WISW (SPF Cqb), Winkelmann, Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks (male), 10 weeks (female)
- Weight at study initiation: 165 g (mean; male), 170 g (mean; female)
- Fasting period before study: yes (16 h before and 4 h after application)
- Housing: Makrolon cages (type III), 5 rats per cage
- Diet (e.g. ad libitum): Altromin 1324 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 31%, 50%
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- Two groups with two different doses (3100 mg/kg bw; 5000 mg/kg bw) and 5 males and 5 females per group.
- 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: several observations at day of application followed by twice a day (once at weekends/bank holidays)
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0 %
- Clinical signs:
- other: Slight clinical signs (bad general condition, sedation, bristled fur, increased diuresis) in all males and females of both dose groups from 1st day (males) and 2nd day (females) after application. All clinical signs were observed to be completely reversed
- Gross pathology:
- No pathological anatomical signs were observed in any animal of both dose groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of Trimethylcarbonsäure in male and female rats was >5000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to EU Method B.1, as published on 19 September 1984 and equivalent to OECD Guideline 401, two dose groups, each with 5 males and 5 females, fasted, 8 -10 weeks old Wistar strain rats given a single oral dose of Trimethylcarbonsäure in Propylene glycol by gavage at a dose of 3100 mg/kg bw and 5000 mg/kg bw and observed for 14 days.
No animal died during the observation period. Slight clinical signs observed in all animals at first until 3rd day of application included bad general condition, sedation, bristled fur, increased diuresis. All clinical signs completely reversed at end of day 3 after application.
Female rats of both dose groups showed a decrease in growth rate in study week 2.
No pathological anatomical signs were observed in any animal of both dose groups.
Oral LD50 (rat, males/females) > 5000 mg/kg bw
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