Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-783-6 | CAS number: 6358-69-6
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- repeated dose toxicity: dermal
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- REPORTS of the Scientific Committee on Cosmetology (seventh series)
- Author:
- Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation
- Year:
- 1 988
- Bibliographic source:
- Scientific Committee on Cosmetology (seventh series), 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- The study was performed to determine the repeated dose – dermal toxicity of the test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
- EC Number:
- 228-783-6
- EC Name:
- Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
- Cas Number:
- 6358-69-6
- Molecular formula:
- C16H10O10S3.3Na
- IUPAC Name:
- trisodium 8-hydroxypyrene-1,3,6-trisulphonate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Type of coverage:
- other: topical application
- Vehicle:
- water
- Details on exposure:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 3.5 mg
substance
Concentration (if solution): (0.05 ml of a 7% solution)
Constant volume or concentration used: yes/no: Yes - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- applied once a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3.5 mg substance (0.05 ml of a 7% solution)
Basis:
no data
- No. of animals per sex per dose:
- 60 mice (sex not specified)
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- Animals were observed for skin tumours and systemic toxicity
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Animals were observed for skin tumours and systemic toxicity
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 3.5 other: mg (0.05 ml of 7% solution)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No signs of toxicity observed after 2 years
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a two year study 60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance in 60 mice for 2 years is 3.5 mg (0.05 ml of a 7% solution)
- Executive summary:
Two year toxicity study was performed to determine the repeated dose – dermal toxicity of the test chemical .60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. No toxicity was observed after 2 years. One mouse out of 60 developed a benign skin tumour (fibroma) near the application site. No control group was used in this study. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance in 50 male mice for 2 years is 3.5 mg (0.05 ml of a 7% solution)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
