1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-September 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Principles of method if other than guideline:

The acute percutaneous toxicity of BCI-MX was investigated in a group of 5 male and 5 female CD rats. The test material was applied to the closely-clipped dorsum of each animal at a dosage of 2000 mg/kg bw, and was covered by an occlusive dressing for 24 hours. Mortality and systemic or local signs of reaction to treatment were recorded during a subsequent 14-day period of observation. The animals were killed on the following day and subjected to necropsy.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

EC Number:

412-570-1

EC Name:

1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Cas Number:

119462-56-5

Molecular formula:

Hill formula: C18 H16 N2 O4

IUPAC Name:

3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione

Details on test material:

- Name of test material (as cited in study report): BCI-MX
Batch no: 910312 (see CoA attached)
Purity: 88±3% (m/m)
Other: mono-citracon-mono-itaconimide isomer: 6.5±2% (m/m)
Unknown: 5.5±2% (m/m)
appearance: cream-white powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female animals.

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: none

Gross pathology:

Effects on organs: none

Other findings:

Signs of toxicity (local): none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 dermal > 2000 mg/kg bw.

Executive summary:

An acute dermal toxicity study (limit test) was performed on male and female Sprague-Dawley rats according to OECD TG 402. No mortalities, clinical signs or local effects were observed during the 14 -day observation period. The resulting dermal LD50 was > 2000 mg/kg bw.