Registration Dossier

Diss Factsheets

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:
other: The study was conducted in compliance with GLP and according to the OECD guideline 401 (acute oral toxicity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
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
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: males 9-10 weeks, females 11-12 weeks (at start of treatment)
- Weight at study initiation: males 175-224 g, females 162-194 g
- Fasting period before study: 15 to 22 hours (food was again presented approximately one hour after dosing)
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL
Doses:
200 mg/kg b.w., 800 mg/kg b.w., 2000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations:
Mortality / Viability: Four times during test day 1, and daily during days 2 - 15.
Body Weights: Test days 1 (pre-administration), 8 and 15.
Clinical Signs: Each animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2-15. All
abnormalities were recorded. The animals were checked for the clinical signs.


Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 319.39 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
908.3 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 106 mg/kg bw
Based on:
test mat.
95% CL:
> 682.22 - < 2 170.79
Mortality:
at 200 mg/kg: no mortality
at 800 mg/kg: 2 males (days 1 and 2) and 1 female (day 1)
at 2000 mg/kg: 3 males (2 on day 1 and 1 on day 2) and 5 females (2 on day 1 and 3 on day 2)
Clinical signs:
other: The following systemic signs were observed: 200 mg/kg: males/females - no clinical signs noted. 800 mg/kg: males/females - sedated, ruffled fur. males - hunched posture. females - la
Gross pathology:
Necropsies were performed by experienced prosectors. All animals were necropsied.
All animals surviving to the end of the observation period were killed by intraperitoneal injection of sodium pentobarbitone.
At 200 mg/kg: dark red dicoloration of lungs in 1 male and pale discoloration of lungs in 1 female
At 800 mg/kg: dark red dicoloration of lungs in each 1 male and female
At 2000 mg/kg: dark red dicoloration of lungs in 3 males, dard red discoloration of jejunum, duodenum, ileum and caecum in 1 male as well as dar or light red discoloration of lungs in each 2 females and reddish discoloration of duodenum and jejunum in 1 female

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these observations, the LOGIT-ESTIMATION for the acute oral toxicity of MATMD in rats of both sexes observed for a period of 15 days is:
1106.12 mg/kg
Executive summary:

For rats of both sexes the Logit-Estimation rersulted in an LD50 of 1106.12 mg/kg.