Registration Dossier
Registration Dossier
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EC number: 700-636-5 | CAS number: 5413-49-0
Endpoint summary
Administrative data
Description of key information
NOAEL (male/female) ≥ 1000 mg/kg/ day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The toxic effects of the test substance to rats after their repeated exposure were evaluated according to the OECD Guidelines 421, 422, 407, EPA OPPTS 870.3650, EPA OPPTS 870.3550, EPA OPPTS 870.3050 and EU B.7. and in GLP compliance. 10 male and 10 female rats were orally exposed to the substance at 0, 100, 300 and 1000 mg/kg bw/day. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to the day prior to scheduled necropsy. Females were exposed for 44-50 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation (up to the day prior to scheduled necropsy). The animals were observed for mortality/viability, clinical signs, functional parameters, food consumption and body weight gain. Blood samples were collected for haematology and clinical biochemistry analysis. The animals were subjected to necropsy, the organ weights and histopathology findings were recorded. No mortality, changes in motor activity or clinical signs of toxicity, were identified. No toxicologically relevant changes occurred in haematological and in clinical biochemistry parameters of treated rats. Necropsy did not reveal any toxicologically relevant alterations and no toxicologically relevant changes were noted in organ weights and organ to body weight ratios.
Treatment with the substance by oral gavage in male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg revealed no parental toxicity up to 1000 mg/kg. Based on these results, a NOAEL of at least 1000 mg/kg bw/day was derived.
As for Annex IX of the REACH Regulation (EC) 1907/2006, a sub-chronic toxicity study (90-day) on one rodent species shall be performed considering the most appropriate route of administration, having regard to the likely route of human exposure. The sub-chronic toxicity of the test substance has be assessed using a Read Across approach with sub-chronic and chronic toxicity data from similar substances/hydrolysis products (Similar Substances 02, 03, 04 and 05) of the test substance.
The NOAEL values determined in the available studies conducted on SS03 and on SS04 are high enough to not result in a classification as STOT-RE 1 or 2, as per the CLP Regulation (EC) No. 1272/2008. Moreover, in a 16-day repeated dose toxicity study via oral route on SS02, the treated animals showed no indication of toxicity at the exposure doses. A detailed evaluation of the repeated dose toxicity of similar substances is attached to the endpoint summary. The justification for the Read Across is given in Section 13 of IUCLID.
The OECD Guideline 422 study performed on the test substance is not a sub-chronic toxicity study as it would have been required for an Annex IX of REACH Regulation; however, in combination with the rest of the available data on the similar substances, the NOAEL identified in the OECD Guideline 422 study on the test substance can be used as the key value for the chemical safety assessment of the test substance. In conclusion, treatment with the test substance by oral gavage in male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg revealed no oral repeated dose toxicity to up to 1000 mg/kg. Based on these results, a parental NOAEL of at least 1000 mg/kg bw/day was derived.
Justification for classification or non-classification
For the classification of the substance as STOT-RE the dose in which significant toxic effects are observed is taken into consideration. If this dose is in the range of the guidance values indicated in the CLP Regulation (EC) No. 1272/2008 Annex I: 3.9.2.9.6 and Annex I: 3.9.2.9.7 then the substance is classified in Category 1 or Category 2 respectively.
Since in the repeated dose toxicity studies on the test substance and on the similar substances no significant toxic effects were observed up to 1000 mg/Kg bw/day, the substance is not classified for STOT-RE according to the CLP Regulation (EC) No. 1272/2008.
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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