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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-10-26 to 1989-11-16
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 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 Feb 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Version: March 1984
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
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: 10 weeks (males) and 12 weeks (females)
- Weight at study initiation: 243 - 264 g (males), 194 - 216 g (females)
- Housing: individually
- 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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped area on the backs of the animals
- % coverage: approximately 10%
- Type of wrap if used: 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.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin was washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 4 mL at 2000 mg/kg bw

Duration of exposure:
24 h
Doses:
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 Day 2 - 15; clinical signs: Each animal was examined for changes in appearance and behavior four times during Day 1, and daily during Day 2-15.
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
Due to the 24 h semi-occlusive treatment, the local skin effects were observed starting on Day 2 of the test.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
The body weight gain of the animals was not affected throughout the study by test article treatment.
Gross pathology:
At 2000 mg/kg bw: dark red lungs in 1/5 females, pale discoloration of lungs in 1/5 females.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the tested conditions, the acute dermal LD50 value in male and female rats was > 2000 mg/kg bw.
CLP: not classified