Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (acute dermal 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 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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 10 weeks, females 12 weeks (at start of treatment)
- Weight at study initiation: males 243 - 264 g, females 194 - 216 g
- Housing: individually
- 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

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on dermal exposure:
Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10% of
the total body surface.
On test day 1 the test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped
around the abdomen and fixed with an elastic adhesive bandage.
Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water and dried with disposable
paper towels.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations:
Mortality I 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 had an examination for changes in appearance and behavior four times during day 1, and daily during days 2-15. All
abnormalities were recorded.
Due to the 24 hour semi-occlusive treatment, the local findings were observed starting with day 2 of test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
At 2000 mg/kg: no mortality, no further dose levels were tested
Clinical signs:
other: The following local symptoms were observed on the back of the animals: 2000 mg/kg: males/females - general erythema, scales. The rats had recovered from erythema after 7 (males) and 14 (females) observation days. Scales were observed in both sexes until d
Gross pathology:
At 2000 mg/kg: In each 1 female dar red or pale discoloration of lungs was noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The toxicity of MATMD was estimated to be greater than 2000 mg/kg.
Executive summary:

The toxicity of MATMD was estimated to be greater than 2000 mg/kg.