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Toxicological information

Skin irritation / corrosion

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study based on national guideline, limited documentation, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
other company data
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Hazardous Substance Act: CFR part 191, Chapter I, Title 21, Fed. Register 26, p. 7333, 12 Aug. 1961 / Fed. Regulation, 29, No. 182, p. 13009, 17 Sep. 1964
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): BR-19
- Substance type: inorganic
- Physical state: solid, white powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Analytical data after ignition: SiO2 (62%); Al2O3 (11.6%); Na2O (8.3%) (see Jones 1975)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded (shaved )
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 g as paste

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg silicate
Duration of treatment / exposure:
24 h
Observation period:
Scoring after 24 and 72 h after test initiation
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: gauze patch, 2 square inch, secured with masking tape
- Type of wrap if used: impervious plastic sheeting around the trunk


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h


SCORING SYSTEM: according to Draize scoring system for erythema, edema, and necrosis primary irritation score (maximum score 8)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0.1
Max. score:
8
Irritant / corrosive response data:
No irritation (erythema or edema) was observed (Report, Tab. III).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating (EU and GHS)