The product from the burning of a combination of carbonaceous materials.

Endpoint summary

Description of key information

Not toxic. LD50 > 2000 mg/kg/day referring to the highest daily dose in the 28-day oral toxicity study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Conclusions:

No toxic effects observed after short-term oral exposure.

Executive summary:

A preliminary trial and dose range-finding study carried out prior to the 28-day oral toxicity study in rats provides adequate information on acute oral toxicity of Ash in rats. In this study groups of 3 male and 3 female rats (altogether 24 rats) were assigned into 4 treatment groups and received Ash in 1% carboxymethyl cellulose by oral gavage at dose-levels of 0, 250, 500 or 1000 mg/kg bw /day for 7 consecutive days. The rats were observed for mortality and clinical signs, food consumption and body weight development. A functional and neurobehavioural test was carried out before dosing and on days 1 and 7. On day 8 the animals were necropsied and examined macroscopically. There was no mortality and no clinical sign in males and females dosed with the vehicle or with Ash at any dose level.

The body weight and food consumption of animals dosed with the vehicle were normal. There was no effect on body weight and food consumption of animals dosed with Ash at any dose level when compared with the vehicle group. There was no macroscopic change in animals dosed with Ash at any dose level when compared with the vehicle group.

Endpoint conclusion

Endpoint conclusion:

no study available

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:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because skin contact in production and/or use is not likely

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Justification for type of information:

Please see the attached WoE document for additional information on dermal exposure

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: Oral

According to Weight of evidence no acute oral toxicity studies are required.

 

Acute toxicity: Dermal

 

The physicochemical and toxicological properties do not suggest potential for a significant rate of absorption through the skin. In addition, skin contact in production and/or use is not likely.

 

Acute toxicity: Inhalation

 

No toxicologically relevant systemic effects were found in the 28-day oral toxicity study at dose levels up to 2000 mg/kg bw/day. Systemic bioavailability is expected to be low. Ash is potentially irritating in the airways.

Justification for classification or non-classification

No classification for acute oral toxicity is required under Directive 67/548/EEC or Regulation EC 1272/2008 (oral 28 d LD50 > 2000 mg/kg). No classification for acute dermal toxicity is required under Directive 67/548/EEC or Regulation EC 1272/2008. The physicochemical and toxicological properties do not suggest potential for a significant rate of absorption through the skin. No toxicologically relevant systemic effects were found in the 28-day oral toxicity study at dose levels up to 2000 mg/kg bw/day. This suggests low systemic bioavailability. No classification for acute inhalation toxicity required under Directive 67/548/EEC or Regulation EC 1272/2008.