Registration Dossier
Registration Dossier
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EC number: 208-237-3 | CAS number: 517-28-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Haematoxylin
- EC Number:
- 208-237-3
- EC Name:
- Haematoxylin
- Cas Number:
- 517-28-2
- Molecular formula:
- C16H14O6
- IUPAC Name:
- haematoxylin
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical signs related to the administration of the test item were observed during the study.
- Body weight:
- The body weight evolution of the animals remained normal during the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the LD50 of the test item hématoxyline (CAS 517-28-2) is higher than 2000 mg/kg body weight.
In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.
The test item hématoxyline (CAS 517-28-2) does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required. - Executive summary:
The test item hématoxyline (CAS 517-28-2) does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.
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.
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