Registration Dossier
Registration Dossier
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EC number: 419-560-6 | CAS number: 4369-14-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to standard US-EPA method and under GLP, skin irritation was observed during both induction and challenge
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 419-560-6
- EC Name:
- -
- Cas Number:
- 4369-14-6
- Molecular formula:
- C9H18O5Si
- IUPAC Name:
- 3-(trimethoxysilyl)propyl prop-2-enoate
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction: 1% w/v
Topical induction: 100 %
Challenge: 100%; 75%
Negative Control: 100% arachis oil
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction: 1% w/v
Topical induction: 100 %
Challenge: 100%; 75%
Negative Control: 100% arachis oil
- No. of animals per dose:
- per test group: 20
negative control group: 10 - Details on study design:
- no data
- Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- skin irritation
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: skin irritation.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- skin irritation
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: skin irritation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- skin irritation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: skin irritation.
- Reading:
- 2nd reading
- Hours after challenge:
- 75
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- skin irritation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 75.0. Group: test group. Dose level: 75%. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: skin irritation.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 1%
Signs of irritation during industion:
Positive skin reaction, very slight to well defined
erythema grades 1 to 2 were noted at the challenge sites of 14/20, 9/20 and 6/20 at 24 and 72 hours observation, respectively
Evidence of sensitisation of each challenge concentration: 14/20 in undiluted 100% test substance, 14/20 in 75% test substance in arachis oil
Other observations: Desquamation was noted at the challenge sites of 3 testgroup animals at 72 hours observation time
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
- Remarks:
- Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- The substance showed irritant effects and is classified as corrosive
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