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Administrative data

Description of key information

The substance is severely irritating and corrosive to the skin, eyes and respiratory tract.
No thresholds are definable for the corrsive/irritant effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP
Qualifier:
no guideline followed
Principles of method if other than guideline:
Non GLP toxicity study.
GLP compliance:
no
Test type:
standard acute method
Species:
other: Rat and Mouse
Sex:
male/female
Route of administration:
oral: drinking water
Vehicle:
water
Control animals:
not specified
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2.81 mL/kg bw
Based on:
test mat.
95% CL:
> 2.34 - <= 3.26
Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Rat - Acute Oral LD50 = 2385 mg/kg
Mouse - Acute Oral LD50 = 2597 mg/kg
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 385 mg/kg bw
Quality of whole database:
The substance is severely irritating and corrosive to the skin, eyes and respiratory tract. Limited conclusions regarding systemic toxicity are possible due to the corrosive effects observed in animals (forestomach corrosion, low urinary pH, clinical indications).

Rat - Acute Oral LD50 = 2385 mg/kg
Mouse - Acute Oral LD50 = 2597 mg/kg

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of five male and five female rats were exposed for four hours in a 160-liter glass and stainless steel chamber to vapors and aerosols of ABBOTT-48832. The highest feasible nominal concentration was 22,5mg/L (actual concentration was not determined at this level). Both nominal and actual exposure concentrations were determined for the LC50 study. The exposure concentrations were as follows :


Actual Concentration Nominal Concentration
(mg/L) (mg/L)
1.1 3.6
1.7 6.3
2.3 8.3
2.4 9.6
2.8 11.3

Aerosols of the test material were generated by metering the liquid with a FMI pump into a spraying system atomizer. An air pressure of 10 psig with an airflow rate of 8 or 10 L/min was applied to the atomizer which aerosolized the liquid for rapid vaporization.
The vapors and aerosols emerging from the atomizer were diluted by the incoming chamber air to the desired concentration.
The size range of aerosol particles was 3.1 + 1.9 mcm.

Observations for signs of toxicity and mortality were made during the 4-hour exposure period and twice daily thereafter for 14 days.

Body weights were recorded on days 0 (prior to exposure), 1, 3, 7 and 14.

Animals that died during the study were necropsied. The surviving animals were necropsied at the end of the 14-day observation period.
GLP compliance:
no
Test type:
fixed concentration procedure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
other: Inhalation - vapour and aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Aerosols of the test material were generated by metering the liquid with a FMI pump into a spraying system atomizer. An air pressure of 10 psig with an airflow rate of 8 or 10 L/min was applied to the atomizer which aerosolized the liquid for rapid vaporization.
The vapors and aerosols emerging from the atomizer were diluted by the incoming chamber air to the desired concentration.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
Actual Nominal
(mg/L) (mg/L)
1.1 3.6
1.7 6.3
2.3 8.3
2.4 9.6
2.8 11.3
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male
Dose descriptor:
LC50
Effect level:
2 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
1.8 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
Up to 0-100% mortality in dosed groups.

Clinical signs:
other: Clinical signs observed were dyspnea, nasal discharge, salivation, evidence of red matter around the face, alopecia and dermal irritation.
Body weight:
All animals exposed demonstrated body weight loss sometime during the first week of the postexposure period.
Gross pathology:
At necropsy red lungs were observed in a few animals from each group. Scattered red patches on the lungs were also observed in a few animals from each group with the exception of Group 111, where the lesion was not observed. Black patches in the thymus was observed in three males and three females during the necropsy.
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the nominal concentrations the calculated 4-hour LC50 for males was 7.4 mg/L, while for the females it was 6.4 mg/L. In terms of actual concentrations, the 4-hour LC50 for males was 2.0 mg/L, while for the females it was 1.8 mg/L.
Executive summary:

Both nominal and actual exposure concentrations were determined for the LC50 study. Nominal concentrations were determined by weighing the amount of test material placed in the generator reservoir prior to exposure and then again following exposure. The difference in weight was divided by the total air passed through the chamber during the exposure period. Actual exposure concentrations were determined by standard gravimetric techniques.

The results indicated that nominal concentrations were higher than actual concentrations, e.g. 11.3 mg/L versus 2.8 mg/L for the highest concentration. Since B.P.>200°C, and vapour pressure=0.172 lb/inch3) this is a liquid material with low volatility, the actual measured concentrations seem more appropriate for evaluation of toxicity.

In conclusion, at actual exposure concentrations of 1.1-2.8 mg/L (nominal concentrations of 3.6-11.3 mg/L) for four hours produced signs of toxicity and deaths in rats. The combined male and female 4-hour LC50 values for actual measured concentrations and nominal concentrations were estimated to be 1.9 mg/L and 6.9 mg/L, respectively.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
1.8 mg/m³
Quality of whole database:
The substance is severely irritating and corrosive to the skin, eyes and respiratory tract.
At necropsy red lungs were observed in a few animals from each group. Scattered red patches on the lungs were also observed in a few animals from each group with the exception of Group 111, where the lesion was not observed. Black patches in the thymus was observed in three males and three females during the necropsy.
Limited conclusions regarding systemic toxicity are possible due to the corrosive effects observed in animals (lung injury).

Acute toxicity: via dermal route

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

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)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
976 mg/kg bw
Quality of whole database:
The substabnce is severely irritating and corrosive to the skin, eyes and respiratory tract. Limited conclusions regarding systemic toxicity are possible due to the corrosive effects observed in animals (forestomach corrosion, low urinary pH, clinical indications).

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)

Additional information

Justification for selection of acute toxicity – oral endpoint
Acute oral toxicity study using the test substance.

Justification for selection of acute toxicity – inhalation endpoint
Acute inhalation toxicity study using the test substance.

Justification for selection of acute toxicity – dermal endpoint
Acute dermal toxicity study using the test substance.

Justification for classification or non-classification

The substance is severely irritating and corrosive to the skin, eyes and respiratory tract.