Octanal, 7-hydroxy-3,7-dimethyl-, reaction products with 1H-indole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Method: Patch test, patch applied to both flanks

GLP compliance:

no

Remarks:

study pre-dates introduction of GLP

Test material

Test material information

Constituent 1

Reference substance name:

η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol

EC Number:

267-434-2

EC Name:

η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol

Cas Number:

67860-00-8

Molecular formula:

C26H32N2O

IUPAC Name:

8,8-di(1H-indol-3-yl)-2,6-dimethyloctan-2-ol

Constituent 2

Reference substance name:

Indole

EC Number:

204-420-7

EC Name:

Indole

Cas Number:

120-72-9

Molecular formula:

C8H7N

IUPAC Name:

1H-indole

Constituent 3

Reference substance name:

7-hydroxycitronellal

EC Number:

203-518-7

EC Name:

7-hydroxycitronellal

Cas Number:

107-75-5

Molecular formula:

C10H20O2

IUPAC Name:

7-hydroxy-3,7-dimethyloctanal

Constituent 4

Reference substance name:

1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol

Cas Number:

1642782-49-7

Molecular formula:

C18H27NO2

IUPAC Name:

1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol

Constituent 5

Reference substance name:

Unknown constituents

IUPAC Name:

Unknown constituents

Specific details on test material used for the study:

Indolene Liquid - solution of 50% Castor Oil of the Schiff's base between hydroxycitronellal and indole

Test animals

Species:

guinea pig

Strain:

not specified

Remarks:

Albino

Details on test animals or test system and environmental conditions:

Albino guinea pigs, four groups of eight animals each

Test system

Type of coverage:

other: patch test

Preparation of test site:

not specified

Vehicle:

other: rectified alcohol

Controls:

yes, concurrent no treatment

yes, concurrent negative control

Amount / concentration applied:

Test concentration: 5%

Duration of treatment / exposure:

Reaction time: 48 hours
Radiation: 4 hours after removal of the patches, the left flank of two groups (A and B) of experimental enimals and of four untreated animals (controls = group D) was radiated as follows:

Group A: with UV-A light
Group B: with UV-B light
Groups C and D = controls:
Group C: underwent no radiation
Group D: was not pretreated and was radiated from both light sources

Radiation time was 30 min for UV-A light and 15 min less than the minimum erythema dose (MED)

Observation period:

The skin reactions were measured 4, 24 and 48 hours after radiation.

Number of animals:

8 animals per group

Results and discussion

In vivo

Results

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions used the preparation showed no skin irritation.

Executive summary:

Patches were applied to both flanks of eight guinea pigs per group followed by irradiation as per group assignment. Skin reactions were measured at 4, 24 and 48 hours after irradiation. No reactions were seen at any timepoints when treated with 5% Indolene with or without irradiation.