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Registration Dossier
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EC number: 422-600-5 | CAS number: 73936-91-1
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: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's Complete Adjuvant and physiological saline (intradermal and epidermal induction); bi-distilled water with one drop of tween 80 (intradermal and epidermal induction, challenge)
- Concentration / amount:
- Intradermal induction:
a) (0.1 mL) 1:1 (V/V) mixture of Freund's Complete Adjuvant and physiological saline
b) The test article, diluted to 5% with bi-distilled water with one drop of tween 80
c) The test article diluted to 5% by emulsion in a 1:1 (V/V) mixture of Freund's Comlete Adjuvant and physiological saline
Epidermal induction:
a) (0.1 mL/site) of a 1:1 (V/V) mixture of Freund's Complete Adjuvant/physiological saline
b) (0.2 mL/site) of 50%, 25%, 15 % and 10% in bi-distilled water with one drop of tween 80
Concentration of test material and vehicle used for each challenge:
15% in bi-distilled water with one drop of tween
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- other: Freund's Complete Adjuvant and physiological saline (intradermal and epidermal induction); bi-distilled water with one drop of tween 80 (intradermal and epidermal induction, challenge)
- Concentration / amount:
- Intradermal induction:
a) (0.1 mL) 1:1 (V/V) mixture of Freund's Complete Adjuvant and physiological saline
b) The test article, diluted to 5% with bi-distilled water with one drop of tween 80
c) The test article diluted to 5% by emulsion in a 1:1 (V/V) mixture of Freund's Comlete Adjuvant and physiological saline
Epidermal induction:
a) (0.1 mL/site) of a 1:1 (V/V) mixture of Freund's Complete Adjuvant/physiological saline
b) (0.2 mL/site) of 50%, 25%, 15 % and 10% in bi-distilled water with one drop of tween 80
Concentration of test material and vehicle used for each challenge:
15% in bi-distilled water with one drop of tween
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 15 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 15 %. No with. + reactions: 0.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 15 %
Evidence of sensitisation of each challenge concentration: None
Other observations: No toxic symptons were evident in the guinea pigs of the control or test group. No deaths occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- On the basis of these results and under the experimental conditions the test substance did not appear to possess sensitising capacity.
- Executive summary:
The test substance was tested to be non sensitising to the skin of guinea pigs in a GLP study according to EU Method B.6.
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