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Administrative data

Description of key information

The test material is not acutely toxic. 
Acute toxicity oral: LD50 3000 mg/kg bodyweight (OECD 401)
Acute toxicity dermal: LD50 > 20000 mg/kg bodyweight (16CFR1500.3)
Acute toxicity inhalation: LC50 > 2000 mg/m3 bodyweight (49CFR173.343 )

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 080 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
2 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
20 000 mg/kg bw

Additional information

Acute Oral Toxicity (in Accordance with 16CFR1500.3):

The oral LD50 was determined to be 3080 mg/kg in male and female Wistar rats. Sublethal effects of lethargy, diarrhea, ptosis, and brown staining at the anogenital area were observed in all dose groups. Necropsy observations included heart, lung, and gastrointestinal abnormalities; no specific organ toxicity is significant; all animals showed expected bodyweight gain during the study course.

 

Acute Dermal Toxicity (in Accordance with 16CFR1500.3):

The dermal LD50 was determined to be > 20,000 mg/kg in male and female New Zealand White rabbits. Toxic signs observed in most animals included lethargy, ataxia, alopecia, and emaciation, no specific organ toxicity is evident.

 

Acute Inhalation Toxicity:

No data on acute inhalation toxicity is available for EC 288-917-4, but weight of evidence suggests that the test material is not toxic via inhalation route for the following reasons: 1) EC 288-917-4 has very low vapor pressure, 2) inhalation exposure is not a human relevant route of exposure, 3) EC 288-917-4 has low toxicity via oral and dermal applications, 4) acute inhalation toxicity tests were performed with the analogous substances EC 283-392-8 (LD50 > 2.3 mg/L vapor) and EC 272-723-1 (LD50 > 2.0 mg/L air) suitable for read-across. These two substances showed low acute inhalation toxicities and are not classifiable and no specific organ toxicity is evident.

This substance does not show any evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401. The rat oral LD50 is 3100 mg/kg in male rats. Sublethal effects of depression, diarrhea, and reduced food intake were observed. Necropsy observations included reduction of body fat, no specific organ toxicity is evident. 

 

This substance does not show any evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402. The rat dermal LD50 is greater than 5000 mg/kg in male rabbits. Severe erythema and edema noted at 24 hours. Necrotic-appearing areas of lung tissue observed in five rabbits. Further histology of the lungs revealed confluent bronchopneumonia or chronic interstitial pneumonia.

 

Integrated testing strategies for acute toxicity state that determination of the most likely route of exposure needs to take into account not only how the substance is manufactured and handled, including engineering controls and risk management measures, but also the physicochemical properties of the substance. The test material has very low volatility. The vapour pressure has been determined to be 4.2x10-4Pa at 25oC, thus there is minimal potential for any inhalation of gases or vapors. ECHA guidance states that for the inhalation route no testing is required if the vapor pressure is very low (< 0.1 Pa at 20oC) (see ECHA Guidance R.7 as well as OECD GD 39). Therefore inhalative acute toxicity is of no relevance.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for acute toxicity.