Registration Dossier
Registration Dossier
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EC number: 400-320-4 | CAS number: 94933-05-8
Endpoint summary
Administrative data
Description of key information
LD50 (oral, rat) > 5000 mg/kg bw
LD50 (dermal, rat) > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity: an experimental study equivalent to OECD Guideline 401 (1981). Sprague-Dawley rats were administered either 4000 or 5000 mg test item/kg bw (5 female and 5 male animals per dose) and monitored for mortality, clinical symptoms and body weight changes for 15 days, then subjected to gross pathological examination.
Acute dermal toxicity: an experimental study equivalent to OECD Guideline 402 (1981). 5 male and 5 female Sprague-Dawley rats were administered a dermal application of 2000 mg test item/kg bw (500 mg test item/ml water) to a shaved, dorsal region for 24 hours then monitored for mortality, clinical symptoms and body weight changes for 15 days, and subjected to gross pathological examination.
Justification for classification or non-classification
According to Annex I: 3.1.2.1 of the CLP Regulation (EC No. 1272/2008), substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in the table below. Acute toxicity values are expressed as (approximate) LD50 (median lethan dose) values for exposure by the oral and dermal routes.
Table 1: Acute toxicity hazard categories defining the respective categories.
| Exposure route | Danger | Warning | |||
| Category 1 | Category 2 | Category 3 | Category 4 | No classification | |
| Oral (mg/kg bw) | LD50≤ 5 | 5 < LD50 ≤ 50 | 50 < LD50 ≤ 300 | 300 < LD50 ≤ 2000 | LD50 > 2000 |
Dermal (mg/kg bw) |
LD50 ≤ 50 | 50 < LD50 ≤ 200 | 200 < LD50 ≤ 1000 | 1000 < LD50 ≤ 2000 | LD50 > 2000 |
According to the studies available, the test item cannot be classified as having an acute oral or dermal toxicity as the LD50 was above 2000 mg/kg bw for both oral and dermal acute exposure.
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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