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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:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guidelines of the Department of Transportation: Code Federal Regulations, Title 49, Part 173
Deviations:
not specified
Principles of method if other than guideline:
Sample Grade 515 Can #20 Grace Powder #7 was evaluated for dermal, acute toxicity following the guidelines of the Department of Transportation.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
EC Number:
930-915-9
Cas Number:
1318-02-1
Molecular formula:
M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
IUPAC Name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
Test material form:
solid: particulate/powder
Remarks:
no surface treatment
Specific details on test material used for the study:
Grace A-Zeolite (NaA), Grade 515
fine white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
Healthy albino rabbits of the New Zealand variety weighing approximately 3 kg were obtained from Skippack Breeding Farms. Rabbits were individually housed in stainless steel suspended cages. Purina Rabbit Chow and water were freely available.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
After a 7-day acclimatisation period, ten (10) rabbits were cliped free of fur over the entire upper back area. Rabbits showing signs of, dermal irritation or lesions were replaced. Five of the test sites were abraded by making a series of five parallel superficial scratches in the dermis; the remaining five were left intact.
The compound was applied at 2 g/kg of body weight to the shaved skin and wrapped with an impervious band which was left in place for 24 hours. Where necessary, the animals were restrained or equipped with an "Elizabethan Collar" to prevent bandage removal.
Duration of exposure:
24 h
Doses:
2 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
Animals were observed for mortality for up to 48 hours.
Treatment sites were evaluated for signs of erythema or edema according to the Draize Scoring System.
Body Weight was recorded at dosing.

Results and discussion

Preliminary study:
none
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No deaths were noted up to 48 hours after application. The dermal LD50 in the rabbit was greater than 2 g/kg body weight.
Clinical signs:
other: No changes were noted in skin condition during the test period.
Gross pathology:
not performed
Other findings:
Draize scores after 24 and 48 hours for erythema and edema were each 0 in all animals.

Applicant's summary and conclusion

Conclusions:
The 48 hour dermal LD55 in the rabbit was estimated at greater than 2 g/kg.
Executive summary:

Sample Grade 515 Can #20 Grace Powder #7 was evaluated for dermal toxicity following the guidelines of the Department of Transportation.