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
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific method and is described in sufficient detail.

Data source

Reference
Reference Type:
other: Final 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 Yellow 124 - CAS No. 34432-92-3 was performed according to the demand given in part 8.8.1 of Annex VIII to the Directive (EC) No. 1907/2006 (REACH): “Assessment of the toxicokinetic behavior 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
- Data from toxicological databases – free and commercial

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Solvent Yellow 124
Substance type: organic
Physical state: liquid
Appearance: dark yellow viscous liquid

Composition of test material, percentage of components:
- Analytical purity: 90.0 % (w/w)
- Impurities (identity and concentrations):
4´-[2-((hydroxy)ethyl)ethylamino]azobenzene 3.0 % (w/w)
1,1-bis(N-ethyl[4-(phenylazo)phenyl]aminoethan-2-oxy)ethan 2.5 % (w/w)
- Unknown impurities 4.5 % (w/w)

Lot/batch No.: S2408
Expiration date of the lot/batch: Unlisted
Stability under test conditions: stable
Storage condition of test material: During the study the test substance was stored in glass bottle at laboratory temperature.

Results and discussion

Any other information on results incl. tables

CONCLUSION

 

After single oral application to rats the substance was absorbed through digestive tract and distributed as itself or metabolites to the skin, fur, visible mucous membranes, subcutaneous and skeletal muscle and deposited in fatty tissue . The substance and /or its metabolites caused dark colour of urine in female rats. So the substance is distributed in the animal body by systemic way.

 

After single dermal application of high dose (2000 mg/kg) of the substance to male and female rats, the substance penetrated through the skin and it was distributed to the fatty tissue. The females seem to be more sensitive.

No symptoms of systemic toxicity were observed in the rabbit during the test period after single application 0,5 ml of the Solvent Yellow 124 onto clipped skin.

This result could be caused by application of much smaller dose or by interspecies difference.

 

The substance is a skin sensitizer in mice. The irritation potential of the test substance was found out after application on ears of mice. This fact pointed to absorption of the substance to the mice organism after dermal exposure.

 

After single application of the substance to conjunctival sac of the rabbit eye the test substance did not demonstrate local irritating effects of eye and systemic toxic effects. It seems that the substance does not penetrate to the body after acute eye exposure.

 

Based on experimental results of long term repeated administration of Solvent Yellow 124 it is possible to conclude that the substance is probably absorbed from gastrointestinal tract and distributed throughout the body of experimental animals to relatively distant compartments, what is demonstrated by the effects on haematological parameters (anaemia) and biochemical parameters (influence to liver metabolism and urinary system function) .

        

Results of Reproduction/Developmental Toxicity Screening Test in rats revealed that the substance at the high dose caused decrease of total number of live pups and mean number of pups per litter. The pups showed yellow colour of fatty tissue, subcutis and milk in stomach. This is the evidence that substance could be distributed through placenta.

 

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

Applicant's summary and conclusion