Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1H-Pyrrole-2,5-dione, 1,1'-(2,4,4-trimethyl-1,6-hexanediyl)bis-

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:

1989

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24 Feb 1987

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

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 levels

Effect levels 1

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

Effect levels 2

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

Effect levels 3

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)