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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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:
Signs of toxicity related to dose levels: none
Body weight:
All animals achieved expected bodyweight gains.
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.