Registration Dossier
Registration Dossier
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EC number: 923-108-8 | CAS number: 1187576-42-6
Endpoint summary
Administrative data
Description of key information
A single oral dose of 2000 mg/kg bw was tolerated withouth mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the LD50 cut-off for the test item is 5000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, AD Horst, Netherlands
- Age at study initiation: 8 -1 2 weeks
- Weight at study initiation: 168 - 215 g
- Fasting period before study: 16 - 24
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- other: none
- Gross pathology:
- no findings
- Other findings:
- none
- Executive summary:
A single oral dose of 2000 mg/kg bw was tolerated withouth mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the LD50 cut-off for the test item is 5000 mg/kg bw.
Reference
| Dose (mg/kg bw) | Toxicological results | Onset and duration of signs | Onset of mortality |
| (1st) 2000 | 0 / 3/ 3 | --- | --- |
| (2nd) 2000 | 0 / 3/ 3 | --- | --- |
Toxicological results:
number of dead animals / number of animals with signs of toxicity after treatment / number of animals treated
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
only one study available
Justification for classification or non-classification
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.
