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Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

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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:
1988
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

Constituent 1
Chemical structure
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

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)