Registration Dossier
Registration Dossier
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EC number: 947-962-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see read across justification section 13.2
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 700 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: no adverse effects noted at the highest dose tested.
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 2 100 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: no adverse effects noted at the highest dose tested.
- Critical effects observed:
- not specified
- Executive summary:
By analogy with data on Propylene glycol, EC 200-338-0, the target substance is considered to have a NOAEL of 1700 mg/kg bw/day in rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 17 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see read across justification section 13.2
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 1 000 mg/m³ air
- Sex:
- female
- Basis for effect level:
- other: based on the decreased body weights of the high-dose females
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 2 200 mg/m³ air
- Sex:
- male
- Basis for effect level:
- other: no adverse effects observed at the highest tested dose
- Dose descriptor:
- LOEC
- Effect level:
- ca. 160 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: based on reported nasal haemorrhaging in all test groups
- Critical effects observed:
- not specified
- Executive summary:
By analogy with data on Propylene glycol, EC 200-338-0, the target substance is considered to have in repeated dose toxicity by inhalation:
a LOEC of 160mg/m3 air
a NOAEC of 1000 mg/m3 air in female and 2200mg/m3 air in male.
Please see read across justification section 13.2
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 160 mg/m³
- Study duration:
- subchronic
- Experimental exposure time per week (hours/week):
- 30
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
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.
