Registration Dossier

Administrative data

Description of key information

Reported oral LD50 values are 3300 mg/kg bw  in rats, and 3800 mg/kg bw in mice. An ester mixture with 26 % submission substance showed an oral LD50 of 2987 mg/kg bw in rats.
For the inhalation route the LC50 in rats was above 0.49 mg/L, the highest concentration tested. A lethal concentration (40-60 % mortality) of 0.040-0.070 mg/L was reported in mice.
No mortality was observed after dermal exposure of rabbits to 5000 mg/kg bw. Therefore the LD50 is above 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 300 mg/kg bw
Quality of whole database:
Results are formally RL4 as secondary source of an unavailable report, but the submitters of report to US EPA considered the results as reliable: "Data reported in a brief memo with limited description of protocol and results.Data were collected prior to GLP and OECD guidelines but by a method comparable to present guidelines/standards and under direction of a recognized research institute. Even though details are not available, the data are considered reliable." Further studies of low reliability support the findings of the selected study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The two available studies were considered to be not reliable

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The available study is formally RL4 as secondary source of an unavailable report, but the submitters of report to US EPA considered the results as reliable: "Data reported in a brief memo with limited description of protocol and results.Data were collected prior to GLP and OECD guidelines but by a method comparable to present guidelines/standards and under direction of a recognized research institute. Even though details are not available, the data are considered reliable."

Additional information

Oral:

Reported oral LD50 values are 3300 mg/kg bw in rats (US EPA HPV, 2001, RL4), and 3800 mg/kg bw in mice (IUCLID, 2000; RL4). An ester mixture with 26 % submission substance showed an oral LD50 of 2987 mg/kg bw in rats (Haskell, 1981; RL3).

The submitters of the report to the EPA considered the LD50 of 3300 mg/kg bw as reliable (formally it would be RL4). All values are clearly above 2000 mg/kg bw, the upper boundary for classification as acute toxic substance after oral exposure. Therefore no classification for acute oral toxicity is necessary.

Inhalation:

The available information is not reliable: Hoechst (1982) reported no mortality at a concentration of 0.49 mg/L. The study is reliable with respect to conceptual design and documentation, but the exposure concentration is too low for definite conclusions on classification.

The other information from secondary source only is a lethal concentration in mice (40 -60 % mortality) of 0.04 -0.070 mg/L. No details are provided. This is in clear contrast to the result of the well-performed study by Hoechst (1982), where no mortality was observed in rats at a 7 -12 fold higher concentration. A species-specific sensitivity difference of this magnitude is not plausible. Therefore, the effects in mice are disregarded.

Dermal:

The available study were rabbits were exposed topically to the test item reported no mortality at a dermal exposure of 5000 mg/kg bw (US EPA HPV, 2001). Though formally as secondary source not assignable, the result was considered to be reliable by the submitters of the report to the US EPA. Therefore no classification for acute dermal toxicity is necessary.


Justification for selection of acute toxicity – oral endpoint
Though formally (as secondary source) not assignable, the study is regarded as reliable in this secondary source

Justification for selection of acute toxicity – dermal endpoint
Though formally (as secondary source) not assignable, the study is regarded as reliable in this secondary source

Justification for classification or non-classification

Based on the available information, the submission substance has not to be classified with respect to oral and dermal exposure (CLP (Regulation (EC) No 1272/2008) and DSD-DPD (Council Directive 67/548/EEC)). No reliable data are available for inhalation exposure.