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:
other: The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
The animals were acquired from Texas Animal Specialties; Humble, TX and maintained in suspended stainless steel with wire bottom, 1 per cage. The male animals weighed 30 1-334 gm and the females weighed 175-204 gm when placed on study. The animals were housed in an animal room at 20-21°C and relative humidity of 41-90% with a 12-hour light/dark cycle and 10-12 air changes/hour.

The animals were offered PMI Feeds Inc.TM Formulab #5008, available ad libitum and Municipal water supply analyzed by TCEQ Water Utilities Division, tap water, available ad libitum (automatic system).




Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The animals placed on study were prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of the total body surface area. Care was taken to avoid abrading the skin. All animals were treated with approximately 2020 mg/kg (1.84 mL/kg) of undiluted test substance. An individual dose was calculated for each animal based on its Day 0 body weight just before exposure. The test substance was applied evenly to each exposure area in a thin, unifonn layer. The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with a semiocclusive veterinary flexible cohesive bandage, secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance.
Duration of exposure:
24 hr
Doses:
Approximately 2020 mg/kg of body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Following dermal exposureaAfter 24 hours, the wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible.

Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14. Observations for evidence of dermal irritation/corrosion were made at approximately 60 minutes after removal of wrappings, and on Days 4, 7, 11 and 14. On Day 14 after dosing, animals were euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.



Statistics:
None required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 020 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Normal body weight gain was observed.
Gross pathology:
Gross necropsy conducted at termination of the study revealed no observable abnormalities.
Other findings:
The dermal findings are as follows. Aftr the 24 hr exposure period 5/10 animals exhibited necrosis. By day 4 7/10 animals exhibited ecchar. At study termination (day 14) 8/10 animals exhibited either eschar or ulceration.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Base on the absence of any mortality. and gross necrospy findings. Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance was determined to have an acute dermal LD50 of > 2020 mg/kg of body weight to the rat suggesting that it is generally nontoxic by the dermal route of exposure. However, the dermal findings indicate that the test substance is corrosive to skin following the prolonged 24 hr exposure period of this study.
Executive summary:

The test substance, Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol was evaluated for acute dermal toxicity and skin irritation to the rat in an O.E.C.D. test guideline 402 study. The test substance was determined to have an acute dermal LD50 of > 2020 mg/kg of body weight to the rat suggesting that it is generally nontoxic by the dermal route of exposure. However, the dermal findings indicate that the test substance is corrosive to skin following the prolonged 24 hr exposure period of this study.