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Diss Factsheets

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:
1989
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

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
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

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)