Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Assessment from available information
Adequacy of study:
key study
Study period:
February - April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Evaluation of toxicokinetics of the substance Solvent Red 19E was performed according to the demand given in part 8.8.1 of Annex VIII to the Regulation (EC) No. 1907/2006 (REACH) : “Assessment of the toxicokinetic behaviour of the substance to the extent that could be derived from the relevant available information”.

The evaluation of toxicokinetics is normally based on information from three sources:
- Experimental data of toxicological tests
- Literature data obtained from internet
- Data from toxicological databases – free and commercial
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The substance did not enter the body via the eye. The substance could enter the body via the skin, at least to deeper layers of dermis and hypodermis. No systemic toxicity after dermal exposure was recorded.
Details on distribution in tissues:
Following repeated oral exposure, the test material was absorbed from the digestive tract and distributed through the body. Evidence of the test material in soem organs and body fat was evident. The main target orgal was probably the liver.
Details on excretion:
No data on excretion on the test material were found.

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
No metabolism data on the substance were found.

Applicant's summary and conclusion

Conclusions:
The material can be absorbed via the oral, dermal and inhalation routes, and is widely distributed around the body. There is no data on the metabolism or excretion of the material. In the absence of quantitative data, for the purposes of risk assessment, absorption values of 100 % (inhalation), 100 % (oral) and 100 % (dermal) are adopted.
Executive summary:

The substance evaluated, Solvent Red 19E, has low acute oral toxicity. Only mild clinical symptoms of intoxication were found (piloerection, gibbous posture) and there was no evidence of systemic toxicity.

The substance did not enter the body via the eye. No irritating effect and no clinical signs of intoxication were detected.

It seems that the substance could enter the body via skin at least to deeper layers of dermis and hypodermis. This conclusion is based on the following observations:

After acute application to the skin, mild clinical signs of intoxication – diarrhoea, and skin around anus coloured were recorded. Moreover diffuse mixed infiltration (mononuclear cells and granulocytes) in dermis was recorded after histopathological skin examination.

In skin sensitisation test the substance elicited increased cell proliferation in the lymph node draining the site of application and this result showed that the test substance has ability to enter the body of mice.

No systemic toxicity after dermal exposure was recorded.

 

Repeated oral exposition to the substance resulted in entering of substance into organism and its systemic distribution. After oral administration, the substance caused systemic intoxication of organism. It is absorbed from digestive tract and distributed through the body of rats. This distribution was confirmed during macroscopic examination of rats – red colouring of some organs and body fat was evident. The main target organ in organism is probably liver. 

With respect to the results of reproduction toxicity part of repeated study it is possible to confirm an adverse effect of the test substance treatment – the total number of pups was decreased. Test substance probably penetrates through the placental barrier – decreased number of pups in treated animals was reported. Development of pups was unchanged.

 

No data about metabolism and excretion of the evaluated substance were found.

In the absence of quantitative data, default absorption values of 100 % (inhalation), 50 % (oral) and 50 % (dermal) are adopted for the purposes of risk assessment in accordance with ECHA guidance.