Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Feb 28, 1990 to March 14, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
yes (Relative humidity was outside the range specified in the guideline but it did not impact the results outcome.)
GLP compliance:
yes (incl. certificate)
Test type:
other: Limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): MON 13900
- Physical state: Brown particles (powder)
- Lot/batch No.: DAY 8912-137OT
- Expiration date of the lot/batch: December, 1993 (estimated)
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Males and female young adult Sprague Dawley rats, obtained from Charles Rivers Laboratories, Inc., Raleigh, North Carolina, were used for the study. The animals were individually housed in suspended stainless steel cages in an environment-controlled room with a 12-h light/dark cycle. Agway Prolab rodent feed arid water was provided to each animal ad libitum. The rats were individually identified using metal ear tags and cage cards. All animals were allowed to acclimate to the laboratory environment for a minimum of 5 d prior to initiation of the study.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was administered to one group of five male and five female rats by a single dermal dose at a level of 5000 mg/kg bw. On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each animal using small animal clippers. The clipped area measured
approx 10% of the animal’s total body surface. Care was taken during clipping to avoid accidental abrasion to the skin. On the following day, 5 male and 5 female rats were weighed and the test substance was applied uniformly over the clipped area at the appropriate dose. Each animal’s dose was contained at the area of application using an 8 ply gauze dressing covered with plastic wrap. A stockinette sleeve was positioned around the trunk of each animal and secured in place using tape. After an exposure period of 24 h, the stockinette sleeve, plastic wrap and gauze dressing were removed. The exposure site on each animal was rinsed with distilled water to remove residual test substance. No attempt was made to quantitate the amount of nonabsorbed test substance. Following dosing, the animals were observed frequently for clinical signs on the day of dosing and once daily thereafter for the duration of the study. Mortality checks were performed twice daily, in the morning and afternoon. Individual body weights were determined and recorded on Days 1, 8 and 15. All animals were subjected to a gross necropsy examination at the time of sacrifice (CO2 asphyxiation).
Duration of exposure:
24 h
Doses:
5000 mg/kg/ bw
No. of animals per sex per dose:
5/sex
Control animals:
not required
Details on study design:
Following dosing, the animals were observed frequently for clinical signs on the day of dosing and once daily thereafter for the duration of the
study. Mortality checks were performed twice daily, in the morning and afternoon. Individual body weights were determined and recorded on Days 1, 8 and 15. All animals were subjected to a gross necropsy examination at the time of sacrifice (CO2 asphyxiation).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No apparent test substance related clinical signs were observed.
Body weight:
Mean body weight maintenance was acceptable for the test period.
Gross pathology:
No remarkable gross internal findings were observed in the animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the acute dermal LD50 of MON 13900 for rats was estimated to be greater than 5,000 mg/kg bw.
Executive summary:

A study was conducted to evaluate the acute dermal toxicity of MON 13900 in rats according to the EPA OPP 81-2 Guideline in compliance with GLP.

A group of male and female rats received a topical application of the test substance at 5,000 mg/kg bw. Following dosing, the rats were observed daily and weighed weekly. No mortality or apparent test substance related clinical signs were observed. Mean bodyweight gain was acceptable. No remarkable gross internal findings were observed in the animals at necropsy.

Under the test conditions, the acute dermal LD50 of the test substance for male and female rats was estimated to be greater than 5,000 mg/kg bw.