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Diss Factsheets

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:
1999

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

Constituent 1
Chemical structure
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

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