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EC number: 915-671-3 | CAS number: -
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-10-23 to 1989-11-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Version: March 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione
- EC Number:
- 915-671-3
- Molecular formula:
- C17H22N2O4
- IUPAC Name:
- Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories Ltd., Fuellinsdorf, Switzerland
- Age at start of treatment: 9-10 weeks (males), 11-12 weeks (females)
- Weight at study initiation: 175-224 g (males), 162-194 g (females)
- Fasting period before study: 15 to 22 hours (food was again presented approximately one hour after dosing)
- Housing: 5 animals/cage
- Diet: pelleted standard Kliba 343 (Kliba Klingentalmuehle, Kaiseraugst, Switzerland), ad libitum
- Water: community tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23 Oct 1989 To: 24 Nov 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 200, 800 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: mortality / viability: Four times during test Day 1, and daily during Days 2 - 15; clinical signs: Each animal was examined for changes in appearance and behaviour four times during Day 1, and daily during Day 2-15.
- Frequency of weighing: Day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- The LOGIT-Model was applied to estimate the toxicity value. Additionally, the 90, 95 and 99% confidence limits for the toxicity for each sex and the slope of the dose response line were estimated.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 319.39 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 90% confidence limit: 527.57 - 5746.58 mg/kg bw
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 908.3 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 90% confidence limit: 453.09 - 3163.45 mg/kg bw
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 106.12 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 682.22 - < 2 170.79
- Mortality:
- at 200 mg/kg bw: no mortality.
at 800 mg/kg bw: 2/5 males (Day 1 and 2) and 1/5 female (Day 1).
at 2000 mg/kg bw: 3/5 males (2 on Day 1 and 1 on Day 2) and 5/5 females (2 on Day 1 and 3 on Day 2) - Clinical signs:
- other: 200 mg/kg bw: males/females - no clinical signs noted. 800 mg/kg bw: 3/5 males and 2/5 females sedated, ruffled fur in 5/5 males and 1/5 females, hunched posture/recumbency in 3/5 males and 1/5 females; all signs were fully reversible by study Day 4 (male
- Gross pathology:
- 200 mg/kg bw: dark red discoloration of lungs in 1/5 males and pale discoloration of lungs in 1/5 females.
800 mg/kg bw: dark red discoloration of lungs in each 1/5 males and females.
2000 mg/kg bw: dark red discoloration of lungs in 3/5 males, dark red discoloration of jejunum, duodenum, ileum and caecum in 1/5 male, as well as dark or light red discoloration of lungs in 2/5 females and reddish discoloration of duodenum and jejunum in 1/5 females.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of the test, the acute oral LD50 value was 1106 mg/kg bw in both sexes combined, 1319.39 mg/kg bw in males and 908.3 mg/kg bw in females.
CLP: Acute Oral 4, H302 according to Regulation (EC) No. 1272/2008 (CLP/EU GHS)
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