Indole

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Remarks:

Smith article: Range-finding toxicity data: list VI + Merck index

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

Single oral dose toxicity is estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, 4-5 weeks of age and 90-120 grams in weight. The dosages are arranged in a logarithmic seeries differing by a factor of two.

GLP compliance:

no

Test type:

other: single dose oral toxicity

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

oral: gavage

Vehicle:

not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

H302 Acute tox 4 oral

Executive summary:

LD50 oral rat = 1000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Quality of whole database:

Klimisch 2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

As indicated in the attached article ( Clark), the typical use of indole is around 200 ppm to 0.01%.
Sometimes this goes up to 1% but above that the odour becomes unpleasant.
Fine fragrances are at most 15-30 % of the total, so at maximum, in an extreme case there would be 0.3 % indole in the end product.
More typically, for say a shampoo or functional product, the fragrance element is only up to 1% of the total product (often 0.2-0.5%) so the amount of indole is extremely low. In any event, the amounts we are talking about in the fragrances themselves are extremely small. The exposure can be negligible.

Endpoint conclusion

Quality of whole database:

vapour pressure 1.6 Pa ( 0.016 hPa) - which is more than 0.1 Pa - no waiving possible. Particle size is less than 100 Micrometer than waiving is possible R7a guidance. Need to measure particle size MMAD ( mass median aerodynamic diameter) with laser diffraction. For it need to spraying the material. IF MMAD is more than 30 Micrometer, than waiving is possible based silicone article. If no waiving possible than need to measure it, since a fragrance has an inhalation route. Since inhalation route is more relevant than dermal route for fragrances, that is why it is recommended to have tested. If dermal acue toxicity is more relevant than no need inhalation acute toxicity. Indole is a natural metabolite found in the human body, from metabolisim of amino-acids, so it is found in human exhaled air. We have no control of the particle size of the perfume user. Need to have a read-across quotation from Manuela.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Penetration of rabbit skin is estimated by a technique losely akin to the one-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5-3.5 kg.

GLP compliance:

no

Species:

rabbit

Strain:

other: New Zealand albino

Sex:

male

Details on test animals or test system and environmental conditions:

4 rabbits were tested.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 790 mg/kg bw

Based on:

test mat.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

H311 Acute tox dermal cat 3

Executive summary:

LD 50 dermal rat = 790 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

790 mg/kg bw

Quality of whole database:

Klimisch 2

Justification for classification or non-classification

H311 Acute tox 3 dermal

H302 Acute tox 4 oral