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

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:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The procedure employed is as followed:

Induction Phase:
Guinea pigs of both sexes, divided in groups of 8 animals each, are shaved on the upper dorsal area. About one hour later, 0.1 ml of the test material is applied to 8 cm2 of the test area. After this pre-treatment, the animals are exposed to the UV B-irradiation for 15' and thereafter to UV A-irradiation for four hours (Westing-house black light tubes) from a distance of 25 cm. The application of the test material and the following irradiation are performed every second day, total nine times in 18 days. Skin reading for evidence of erythema is made 24 hours after each application.

Challenge Phase:
After a rest period of ten days, the guinea pigs are shaved on both flanks and the test area marked. 0.025 ml of the test material is applied to 2 cm2 of both skin sites, for challenging. Then, the left flank only is irradiated in the same way as described for induction. Skin reading for evidence of erythema is made 24 hours and 48 hours after challenging. The reactions on the left and right flank are compared for estimation of the photosensitizing capacity. Moreover, a control group of six animals is tested and read just as the experimental group during the challenge phase.

GLP compliance:

no

Remarks:

study pre-dates introduction of GLP

Type of study:

other: Guinea Pig Assay of Photosensitizing potential

Justification for non-LLNA method:

LLNA not available at time of testing

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:

Test Material: Indolene Liquid, 50% Indolene in Castor Oil

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

The guinea pig is the animal of choice for studying the sensitizing capacity of single chemical compounds, pharmaceutical and cosmetic products. The guinea pig has proved to be useful for identifying potential photosensitizers.

Study design: in vivo (non-LLNA)

No. of animals per dose:

8 animals per group

Details on study design:

Induction Phase:
Guinea pigs of both sexes, divided in groups of 8 animals each, are shaved on the upper dorsal area. About one hour later, 0.1 ml of the test material is applied to 8 cm2 of the test area. After this pre-treatment, the animals are exposed to the UV B-irradiation for 15' and thereafter to UV A-irradiation for four hours (Westing-house black light tubes) from a distance of 25 cm. The application of the test material and the following irradiation are performed every second day, total nine times in 18 days. Skin reading for evidence of erythema is made 24 hours after each application, according to the following scale:

0 = no erythema
1 = slight erythema
2 = moderate erythema
3 = strong erythema

Challenge Phase:
After a rest period of ten days, the guinea pigs are shaved on both flanks and the test area marked. 0.025 ml of the test material is applied to 2 cm2 of both skin sites, for challenging. Then, the left flank only is irradiated in the same way as described for induction. Skin reading for evidence of erythema is made 24 hours and 48 hours after challenging. The reactions on the left and right flank are compared for estimation of the photosensitizing capacity. Moreover, a control group of six animals is tested and read just as the experimental group during the challenge phase.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5% Indolene

No. with + reactions:

0

Total no. in group:

8

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5% Indolene

No. with + reactions:

0

Total no. in group:

8

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under test conditions used the 10% solution of Indolene Liquide (i.e., 5% Indolene) showed no photosensitizing potential.

Executive summary:

In a guinea pig photosensitizing assay, 8 guinea pigs were exposed to 5% Indolene nine times over 18 days. After a ten-day rest period, the animals were challenged with 5% Indolene and scored for erythema at 24 and 48 hours. No erythema was observed and Indolene was judged to be non-sensitizing at 5% under the test conditions.