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Registration Dossier
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EC number: 215-199-1 | CAS number: 1312-76-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Oct 2004 - 16 Dec 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods; GLP
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only historical positive control, one dose tested
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs
- Age at study initiation: young adult
- Weight at study initiation: 310 - 418 g
- Housing: group housing in stainless steeel cages
- Diet (e.g. ad libitum): pelleted Purina guinea pig chow #5025
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 3, 6 or 40 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Oct To: 19 Nov 2004 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100% (undiluted, induction exposure), 75% (challenge exposure)
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100% (undiluted, induction exposure), 75% (challenge exposure)
- No. of animals per dose:
- 20 in test group and 10 in naive control group
- Details on study design:
- RANGE FINDING TESTS:
Test to determine the highest non-irrritating concentration of the test substance to be used as challenge dose. The test substance was applied in concentrations of 100, 75, 50 and 25% to the shaved test side using an occlusive Hill Top Chamber and gently removed after 6h exposure (identical to main study). Approximately 24 h after application, each site was evaluated for local irritation reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 weeks
- Site: left side of each animal
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 100%
B. CHALLENGE EXPOSURE
27 days after the first induction dose
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 h
- Site: right side of each animal
- Concentrations: 75%
- Evaluation (hr after challenge): 24 and 48 h after the challenge application - Positive control substance(s):
- yes
- Remarks:
- technical alpha-hexylcinnamaldehyde (historical control)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%/75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema in 8/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%/75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema in 8/20 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%/75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- one animal with very faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%/75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: one animal with very faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%/75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema in 4/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%/75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema in 4/10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%/75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%/75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- 1-fluoro-2,4-dinitrobenzene (DNFB) as positive control
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Source: National Cancer Institute, USA
- Age: 45 - 60 days
- Weight at study initiation: 17 - 20 g - Vehicle:
- other: 15% ethanol
- Concentration:
- 2, 4 and 6%
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: A primary irritancy assay was performed to establish the minimal irritating and the maximal non-irritating concentration.
TREATMENT PREPARATION AND ADMINISTRATION:
Test solutions were prepared daily in amber vials using 15% ethanol. - Positive control substance(s):
- other: 1-fluoro-2,4-dinitrobenzene (DNFB)
- Statistics:
- Bartlett's chi-square Test, one-way ANOVA and Dunnett's Multiple Range t Test
- Remarks on result:
- other: please refer to 'any other information on results incl. tables'
- Interpretation of results:
- not sensitising
Referenceopen allclose all
The first and the second reading of the historical positive control group gave 6/10 animals with positive reactions whereas the corresponding negative control group (5 animals) gave no reactions at both time points.
RESULTS OF PILOT STUDY: minimal irritating concentration: 6%; maximal non-irritating concentration: 4%
RESULTS OF TEST
- Sensitization reaction: sensitization with 2-6% did not significantly alter cell proliferation in the auricular lymph nodes,
even though an increase of 30% and 40% at the 4% and 6% treatment levels was measured, respectively. A greater than
30-fold increase was measured in the positive control.
Endpoint conclusion
- Additional information:
Potassium silicate as well as the read-across substance, sodium metasilicate, were not sensitizing in two different skin sensitisation tests (Buehler test and local lymph node assay). In a human case report, contact urticaria induced by sodium silicate was observed in one individual.
Migrated from Short description of key information:
Potassium silicate is not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Not required. No data available.
Justification for classification or non-classification
The available data is conclusive but not sufficient for classification.
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