Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-guidleine.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male and female New Zealand albino rabbits3 weighing 2.06 to 2.97 kg each were used.

Before treatment, the back of each rabbit was clipped free of hair to prepare a site of application constituting approximately 10% of the total body surface area (approximately 150 to 250 square centimeters). Immediately before application of the test material, the treatment sites of half of the rabbits were further prepared by making four minor epidermal incisions at two to three centimeter intervals longi- tudinally over the area of exposure. Bleeding was not induced.

A single dose of the test material was applied evenly over the application site of each test rabbit. Groups of five males or five female were treated with dosages ranging from 0.86 to 2.00 mllkg. After application of the test material, the entire trunk of each animal was wrapped with a thin plastic film secured in place with tape and a gauze over-wrap.

Twenty-four hours later the wrapping was removed and excess test material was gently wiped (not washed) off the test site.

After treatment all animals were observed twice each day for two weeks for fatalities and signs of systemic toxicity. Local effects were recorded once each day. The body weights of all animals were recorded at the time of treatment, one week later, and at necropsy.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test material was applied topically to the shaved and intact or abraded skin at dosages ranging from 0.86 to 2.00 ml/kg. The test site was then covered with an occlusive plastic film for 24 hours.
Duration of exposure:
24 hours
Doses:
0.86 to 2.00 ml/kg.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 220 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Unabraded skin
Sex:
female
Dose descriptor:
LD50
Effect level:
1 171 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Unabraded skin
Sex:
male
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Abraded skin
Sex:
female
Dose descriptor:
LD50
Effect level:
976 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Abraded skin
Gross pathology:
POLYCAT 9 produced marked local irritation and corrosion.
Other findings:
POLYCAT 9 was very irritating, corrosive and systemically toxic when applied to the skin of rabbits. Local effects were not reversible within two weeks. Signs of systemic toxicity including hematuria, decreased activity and ataxia were observed at all dosages (0.86 to 2.00 ml/kg) for up to a week after treatment.
The minimum lethal dosage was 1.10 ml/kg and LD50 values ranged from 1.15 to 1.65 ml/kg. No sex-related differences in toxicity were observed. Also, abrading the skin prior to treatment did not appear to enhance the toxicity of the test material.

Signs of systemic toxicity including hematuria, decreased activity, ataxia and dyspnea were also observed. Liver discoloration and hemorrhagic changes in the stomach, lungs and kidneys were observed macroscopically and dermal necrosis and subcutaneous hemorrhages, edema and inflammation were observed microscopically in rabbits treated with POLYCAT 9.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Polycat 9 is severely irritating and corrosive to the skin, eyes and respiratory tract.
Executive summary:

Male Rabbit LD50 1120 mg/kg (unabraded skin)

Female Rabbit LD50 1171 mg/kg (unabraded skin)

Male Rabbit LD50 1400 mg/kg (abraded skin)

Female Rabbit LD50 976 mg/kg (abraded skin)