Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
a off-white powdery solid, without irritating odor

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Age at First Dose 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health The health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated to the condition identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, up to 2-3 animals per cage, males and females separately in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 23.36 ± 0.2° C, relative humidity within 54.58 ± 1.9 %. The light regimen was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving. A precise amount of the test item was aspirated into an adjustable pipette and applied directly on the shaved skin of the back in a single dose uniformly over an area approximately 10 % of the total body surface area. Test item was held in contact with the skin by using semi-occlusive dressing with non-irritating tape throughout the 24-hours exposure period. At the end of the exposure period, any residuals of the test item were removed by using lukewarm water without altering the existing response or integrity of the epidermis.
Duration of exposure:
24-hours exposure
Doses:
50, 200, 1000, and 2000 mg/kg body weight
No. of animals per sex per dose:
5 males and 5 females

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All 5/5 females and 5/5 males at the limit dose of 2000 mg/kg body weight survived.
Clinical signs:
No mortality was observed during the study. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
Body weight:
The body weight of all females increased during the study, stagnation of body weight in two females was noticed. Stagnation of body weight in three males was observed between the first and second week. No body weight losses in males were observed between first and second week after application of the test item.
Other findings:
All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.
All animals (5 females and 5 males) were necropsied. During necropsy, no macroscopic changes were noticed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on OECD Guideline 402 and OECD Guideline Draft 434 it can be concluded, that for the test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one according to the Globally Harmonised System and Category Labelling of Chemicals can be classified in Category 5/Unclassified with LD50 value greater than 2000 mg/kg body weight after single dermal application to Wistar rats.