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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
19 - 22 Dec 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Kaolin, calcined (CAS 92704-41-1). 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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): M-96-018
- Code: PSL Code number E61114-2R
- Physical state: white powder
- Analytical purity: not stated
- Composition of test material: Kaolin clay polydimethylsiloxane
- Lot/batch No.: Lot #08145
- Expiration date of the lot/batch: not applicable
- Stability: stable
- Storage condition of test material: at room temperature
- Other: solubility: suspendable in distilled water

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Species/strain: New Zealand albino
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: adult
- Housing: singly housed in suspended stainless steel caging with mesh floors (which conform to the size recommendations in the Guide for the Care and Use of Laboratory Animals DHEW No. 86.23.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 13 days
- Contaminants: Analyses of the food and water are conducted at least once a year

ENVIRONMENTAL CONDITIONS
- Temperature: 17.8 - 18.3 °C
- Photoperiod: 12 hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): five-tenths of a gram of the test substance
- Concentration (if solution): 50% w/w mixture in distilled water (dry paste)

VEHICLE
- Concentration (if solution): 50% w/w mixture in distilled water (dry paste)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: 3" Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test sites were gently wiped with water and a clean towel
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize

Three males and three females were tested. The test substance was moistened to achieve a dry paste. 0.5 grams was applied to one 6 cm² intact dose site on each animal and covered with a 1x1", 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive tape. Elizabethan collars were placed on each rabbit. After 4 hours of exposure to the test substance, the pads and collars were removed and the test site was wiped off any residual test substance.

The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Individual dose sites were scored at approx. 1, 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information