Registration Dossier

Administrative data

Description of key information

Acute oral toxicity:

The acute oral toxicity study was carried out based on the guidelines described in:

OECD No.423 (2001) "Acute Toxicity-Oral, Acute Toxic Class Method"

EC, Council Directive 67/548/EEC, Annex V, B.1 tris (2004) "Acute Oral Toxicity" EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity- Acute Toxic Class Method" JMAFF guidelines (2000) including the most recent partial revisions.

The test substance was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred.

Hunched posture in all animals and uncoordinated movements and/or piloerection in two animals were noted on Day 1.

The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Acute inhalanation toxicity:

The study was carried out based on the guidelines described in:

-"Acute Inhalation Toxicity", OECD No.403, Draft document (1996).

- European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 92/69/EEC, B2: "Acute Toxicity-Inhalation". Official Journal of the European Communities No. L 383, 1992.

- EPA Health Effects Test Guidelines OPPTS 870.1300, Acute inhalation Toxicity. EPA 712-C-98-

193, August 1998.

- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No

8147, November 2000, including the most recent partial revisions.

The test susbatnce was administered by inhalation for 4 hours to one group of five male and five female Wistar rats. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

The mean actual concentration was 5.9 ± 1.3 mg/L The nominal concentration was 17.9 mg/l. The generation efficiency (ratio of actual and nominal concentration) was 33%.

The particle size distribution was characterized twice. The cumulative particle size distribution showed an elongated tail at the smaller particle size. It was concluded that the particle size distribution was not lognormally distributed and a geometric standard deviation could not be calculated. The mass median aerodynamic diameter (MMAD), the diameter at which the cumulative percentage amounts to 50%, was estimated from the graphs displaying the cumulative particle size distribution. The MMAD was 3.6 and 3.8 micron respectively.

No mortality occurred.

During exposure no clinical signs were noted.

After exposure the following clinical signs were noted: hunched posture, piloerection, laboured respiration, slow breathing, rales, chromodacryorrhoea, brown staining of the head and or snout.

The surviving animals had recovered from the symptoms at day 3.

White staining of the head by the test substance was observed up to day 2 and was considered to be caused by the test substance.

Body weight loss or reduced weight gain was shown by the majority of the animals during the first week after exposure. During the second week after exposure weight gain had recovered in the majority of the animals. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain .

No abnormalities were found at macroscopic post mortem examination of the animals.

The inhalatory LC50, 4h value of the test substance in Wistar rats was established to exceed 5 mg/L.

Acute dermal toxicity:

The acute dermal toxicity results were read-across from a close structural analogue:

According to OECD, EPA and JMAFF test guidelines, the test substance was administered to five Wistar rats of each sex by a single dermal application of 2000 mg/kg bw for 24 hours. No mortality occurred. Flat posture, ptosis and/or chromodacryorrhoea were noted among the animals on day 1. Scales, scabs and/or erythema were seen in the treated skin-area of the animals (1/5 males, 5/5 females) during the observation period which disappeared before the end of this period, day 15, except for 1 female. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Quality of whole database:
Reliability 1

Additional information

Justification for classification or non-classification

Based on the studies present, the test substance does not meet classification criteria according to CLP Regulation (EC) No 1272/2008 for acute oral, dermal or inhalation toxicity.