Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics

Type of information:

other: Toxicokinetic behavior of PR247 has not been investigated experimentally.

Adequacy of study:

key study

Qualifier:

no guideline required

Principles of method if other than guideline:

expert statement based on available information

GLP compliance:

no

Type:

absorption

Results:

no absorption expected

Type:

distribution

Results:

no distribution as no absorption expected

Type:

metabolism

Results:

no metabolism expected as no absorption expected

Type:

excretion

Results:

no excretion expected as no absorption expected

Metabolites identified:

no

Bioaccessibility (or Bioavailability) testing results:

The test material is not expected to become bioavailable

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Based on the assessment of the toxicokinetic behaviour of PR 247 to the extent that can be derived from the relevant available information PR 247 is considered not to be bioavailable in relevant amounts.

Executive summary:

Toxicokinetic behavior of PR 247 has not been investigated experimentally. However, taking into account the physical-chemical data and the toxic properties of PR 247 and of pigments with similar chemical structures (analogues), some conclusions on the toxicokinetics of PR 247 can be drawn.

No relevant substance specific toxicity has been observed in several studies on toxicity after oral or dermal exposure:

• PR 247 or its analogues are not acutely toxic, neither after oral nor after dermal application. The LD50 values are >2000 mg/kg bw, the limit for classification.

• Investigations on the toxicity after repeated dosing did not reveal any toxicity up to the highest dose tested (OECD 407, RA from PR 146, NOAEL: >1000 mg/kg bw, OECD 407, RA from PR 112, NOAEL: >1000 mg/kg bw, OECD 422, RA from PR 022, NOAEL: >1000 mg/kg bw, OECD 407, RA from PR 170, NOAEL: ca1200 mg/kg bw)

• PR 247 is not irritating to the skin, i.e. it does not damage the skin barrier, which would facilitate dermal absorption.

• PR 247 does not cause skin sensitisation.
• Several tests on mutagenicity in vitro gave negative results. The data on mutagenicity indicate that the azo-group of the chemical structure is very stable and is not cleaved, especially not under conditions of metabolic activation.

• Analogues of Pigment Red 247 do not cause any reproductive toxicity (development or fertility)

These data on toxicity indicate that PR 247 is not bioavailable in toxic amounts after oral or dermal exposure.

PR 247 is practically insoluble in water and n-octanol. Due to this fact PR 247 is (nearly) not existent in a dissolved form on the skin or mucous membranes after dermal or oral exposure, i.e. it could not be absorbed via skin and mucous membranes.

All these data indicate that PR 247 does not become bioavailable in relevant amounts. But, upon inhalation of a pigment product with a particle size distribution allowing deposition in the lower respiratory tract, uptake and transport of pigment particles by macrophages may occur as for other inert dust particles.

 

The conclusion that PR 247 is practically not bioavailable except after uptake from the lower respiratory tract by macrophages is supported by findings on other (nearly) insoluble and inert pigment particles like e.g. Mono-Azo Pigments, Diarylide Yellow Pigments, Quinacridone Pigments, Acetolone or Naphtolone Pigments. The members of these pigment groups have similar physical-chemical properties like the PR 247, i.e. they are also nearly insoluble in water, n-octanol or other organic solvents. Like PR 247 the members of the other pigment groups did not show any substance related toxicity in several studies on acute or repeated dose toxicity. Published investigations on toxicokinetic behaviour revealed a negligible uptake, if at all, after oral (Decad et al., 1983; El Dareer et al., 1984;Leuschner 1978; Mondino et al., 1978; Nony et al., 1980; Sagelsdorff et al., 1996) , inhalative (Bartsch et al., 2001; Hofmann and Schmidt, 1993) or dermal application (Decad et al., 1983).

Description of key information

no bioaccumulation potential based on study results
Based on the assessment of the toxicokinetic behaviour of PR 247 to the extent that can be derived from the relevant available information PR 247 is considered not to be bioavailable in relevant amounts.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential