Registration Dossier
Registration Dossier
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EC number: 233-175-9 | CAS number: 10049-36-2
Endpoint summary
Administrative data
Description of key information
Acute Toxicity: Oral
-LD50 > 2000 mg/kg bodweight in female rats
Acute Toxicity: Dermal
-Study not required according Annex VII standard information reequirements for substances manufactured or imported in quantities of one tonne or more if the oral LD50 is > 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Quality of whole database:
- The key study was conducted under GLP conditions in accordance with the standardised guidelinesOECD 423 and EU Method B.1 tris. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Toxicity : Oral
TEA borate was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg bodyweight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15)
No mortality occured. Clinical signs of toxicity included hunched posture and piloerection for four out of six animals on Day 1 only. The mean body weight gain shown by the animals over the study period was considered to be normal.
One animal showed pelvic dilation on the right side of the kidneys, since this is oxxasionally seen among rats of this age and strain and it was found in one animal only, this was considered not toxicologically significant. No test item related abnormalities were found at macroscopic post mortem examination of the remaining animals.
The oral LD50 value of TEA borate in Wistar rats was established to exceed 2000 mg/kg body weight. According to OECD 423 testguideline, the LD50 cut-off value was considered to exceed 5000 mg/kg.
Justification for classification or non-classification
Based on these results, TEA borate does not have to be classified and has no obligatory labelling requirment for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and REgulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments)
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