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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
30 Dec 1996 - 13 Jan 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-guideline study, tested with the source substance Kaolin clay. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
other: one single dose
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Satintone 5HB
- PSL Code Number E61114-1R
- Physical state/appearance: white powder
- Analytical purity: no data
- Composition of test material, percentage of components: Kaolin clay - 100%
- Lot/batch No.: Lot no. 10146
- Expiration date of the lot/batch: not applicable
- Stability: stable
- pH: 5-6
- Solubility: suspendable in water
- Storage condition: room temperature
The sample was applied as a 50% w/w mixture in distilled water (highest concentration of the test substance in water that formed a dry paste)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: young adult
- Weight at study initiation: males 232-240 grams, females 216-238 grams
- Housing: stainless steel cages, mesh floor, litter paper, cages are conform to the size recommendations in the guide for the Care and Use of laboratory Animals DHEW (NIH) No. 86.23
- Diet (e.g. ad libitum): Purina Rodent Chow No. 5012
- Water (e.g. ad libitum): ad libitum filtered tap water (by an automatic water dispensing system)
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (° F): 67-71 °F
- Temperature (° C): 19.4 - 21.7 °C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
The test substance was applied as paste to the skin of 10 healtyh animals for 24 hours. On the day prior to application, the animals were prepared by clipping the dorsal area and the trunk.

TEST SITE
- Area of exposure: 2x3"
- % coverage: approx. 10% of the body surface
- Type of wrap if used: 4-ply gauze pad, 3" Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water (drying with a clean towel)
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 - 2.4 g of test paste
- Concentration (if solution): 50% w/w suspension (dry paste)
- Constant volume or concentration used: yes, 5000 mg/kg bw; actual dose/range 4.955 - 5.093 mg/kg bw
- For solids, paste formed: yes

VEHICLE: distilled water
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage-side observation were performed 1 and 3 hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Individual bodyweights were recorded prior to test substance administration and again on days 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (tissues and organs of the thoracic and abdominal cavities)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived.
Clinical signs:
All animals survived, gained weight and appeared active and healthy after dermal application of 5000 mg/kg bw test substance. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Body weight:
All animals gained weight.
Bodyweight range (males):
inital: 232 - 240 g, day 7: 295 - 314 g, day 14: 316 - 379 g
Bodyweight range (females):
initial: 216 - 238 g, day 7: 219 - 246 g, day 14: 240 - 264 g
Gross pathology:
Gross necropsy findings at terminal sacrifice were generally unremarkable. Apart from red lung discoloration consistent with euthanasia via CO2 inhalation, all tissues and organs appeared normal.

Applicant's summary and conclusion