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EC number: 431-020-1 | CAS number: 41340-36-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- not specified
Test material
- Reference substance name:
- 2-(7-ethyl-1H-indol-3-yl)ethanol
- EC Number:
- 431-020-1
- EC Name:
- 2-(7-ethyl-1H-indol-3-yl)ethanol
- Cas Number:
- 41340-36-7
- Molecular formula:
- C12H15NO
- IUPAC Name:
- 2-(7-ethyl-1H-indol-3-yl)ethan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: guinea pigs - Ibm: GOHI; SPF-quality guinea pigs
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saling.
2) The test article, at 1% in PEG 400.
3) The test article at 1% in a 1:1 (v/v) mixture of
Freund's Complete Adjuvant and physiological saline.
Epidermal:
Undiluted test article, a volume of approximately 0.3 ml.
Concentration of test material and vehicle used for each challenge:
Two patches of filter paper were saturated with the test
20
article at the highest non-irritating concentration of 25%
(left flank) and the vehicle only (PEG 400 applied at the
right flank) using the same method as for the epidermal
application. The volume of test article preparation and
vehicle applied was approximately 0.2ml.
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saling.
2) The test article, at 1% in PEG 400.
3) The test article at 1% in a 1:1 (v/v) mixture of
Freund's Complete Adjuvant and physiological saline.
Epidermal:
Undiluted test article, a volume of approximately 0.3 ml.
Concentration of test material and vehicle used for each challenge:
Two patches of filter paper were saturated with the test
20
article at the highest non-irritating concentration of 25%
(left flank) and the vehicle only (PEG 400 applied at the
right flank) using the same method as for the epidermal
application. The volume of test article preparation and
vehicle applied was approximately 0.2ml.
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- 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: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- 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: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- 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: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
As the test article stained the skin brown, it was not possible to determine whether erythema was present or not
after treatment with the undiluted test article. However, no oedema was observed.
Evidence of sensitisation of each challenge concentration:
Control group:
No skin reactions were observed in the animals when treated with either PEG 400 only or when treated with the test
article at 25% in PEG 400.
A slight brouwn discoloration was noted directly after removal of the patch. To remove the discoloration all
animals wre depilated approximately 3 hours prior to challenge reading.
Test group:
Discrete/patchy erythema was observed in one out of 10 animals at the 24- and 48-hour reading after treatment with
the test article at 25% in PEG 400. No skin reactions were observed in the animals with PEG 400 only.
Other observations:
One animal of the control group was found dead on test day 15 (i.e. one week after the epidermal induction
application). At necropsy, no findings were noted. The cause of death could not be established. The death was considered
to be spontaneous and treatment-unrelated.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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