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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Referring to acute toxicity, validated GLP studies are available for the oral and the dermal route of exposure. No study is available for inhalation toxicity, however, it could be demonstrated that the conduct of such a study is scientifically unjustified.
The acute oral toxicity was assessed in a study conducted according to OECD 401 (RCC 205514) and the LD50 was > 5000 mg/kg bw
The acute dermal toxicity was assessed in a study conducted according to OECD 402 (RCC 205525) and the LD50 was > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

A study was conducted according to the OECD TG 401 for assessment of the oral acute toxicity of the test article (RCC 205514). For this purpose, a single dose of 5000 mg/kg bw was administered to five male and five female Wistar rats by gavage. This was followed by an observation period of 15 days during which the animals were regularly checked for mortality and clinical symptoms; body weight changes also were recorded. At the end of the observation period, the animals were sacrificed for the purpose of necropsy and were subjected to gross pathology. Neither mortality nor clinical symptoms were evidenced, resulting in a LD50 > 5000 mg/kg bw.

A study was conducted according to the OECD TG 402 for assessment of the dermal acute toxicity of the test article (RCC 205525). For this purpose, a single dose of 2000 mg/kg bw was applied under occlusive conditions to the shaved skin of each of five male and five female Wistar rats. This was followed by an observation period of 15 days during which the animals were regularly checked for mortality and clinical symptoms; body weight changes also were recorded and the skin was examined for reaction. At the end of the observation period, the animals were sacrificed for the purpose of necropsy and were subjected to gross pathology. Neither mortality nor clinical symptoms were evidenced; skin reactions consisting of erythema and yellow discoloration at the application site were transient. Thus, the LD50 was > 2000 mg/kg bw.

No acute toxicity study is available for the inhalation route of exposure, however, it is possible to waive this endpoint on the basis of the following argumentation. According to column 2 of REACH Annex VIII and with respect to the acute toxicity, at least one further route of exposure (dermal, inhalation) must be provided in addition to the oral route. The further route has to be selected according to the possible route of human exposure during manufacture, handling and use of the test article. In present case, the dermal administration was tested because this is a possible route of human exposure during manufacture, handling and use of the test article.

With respect to the inhalation route, the test article is described as an orange powder (see IUCLID chapter 4.1) and since the substance is amorphous, only the vapour pressure for the liquid or amorphous form could be calculated. The vapour pressure was thus measured by means of thermogravimetry (TG, diffusion controlled evaporation; see IUCLID chapter 4.6) under following experimental conditions:

Sample weight: 3.64 mg of the test substance

Heating rate: 20°C/min

Atmosphere: N2

4 scan with the same sample

1. Scan: 25°C to 100°C, about 3.9 % evaporation of sample

2. Scan: 25°C to 145°C, about 4.6 % evaporation of sample

3. Scan: 25°C to 145°C, about 5.0 % evaporation of sample

4. Scan: 25°C to 145°C, about 5.3 % evaporation of sample

The following values were extrapolated:

VP ≤ 0.0019 Pa (at 25 °C)

VP ≤ 0.0011 Pa (at 20 °C)

Volatiles in temperature region 25°C to 100°C were about 6%

Only approximated upper limits of vapour pressure were given, because the sample possibly decomposes during the thermal treatment. This assumption was based on the fact that (1) the beginning of evaporation (weight loss) of the sample measured by the TG-method was at about the same temperature as the beginning of an exothermic energy measured by the DSC-method, and that (2) the TG curve was anomalous since only the vapour pressure for the liquid or amorphous form could be calculated.

Particle size distribution analysis was performed on a CILAS Granulometer Model 715 (see IUCLID Chapter 4.5). The measuring technique of this instrument is based on the principle of light diffraction. A laser beam passes through the particle suspension and produces a diffraction pattern, which is measured and analysed by the instrument.

The test substance could not be analysed in accordance with the OECD Guideline for Testing of Chemicals No. 110 "Particle Size Distribution/FibreLength and Diameter Distributions" because the suggested methods gave irreproducible results. A mass median diameter (MMD) of 23.4 µm was reported. 0% particles were > 192 µm, 77% particles were > 10 µm and only 7.2% were < 4 µm. Therefore, the majority of generated particles will not penetrate into the broncho-alveolar tract.

Thus, due to the physicochemical characteristics mentioned above, and taking into account that the substance shows no general toxic potential (LD50 acute oral above 5000 mg/kg bw, LD50 acute dermal above 2000 mg/kg bw), an acute inhalation study will not be performed with respect to animal welfare.

Justification for classification or non-classification

Valid data are available for both, the oral and the dermal route of exposure. These data revealed an LD50 value > 5000 mg/kg bw and > 2000 mg/kg bw, for acute oral and acute dermal toxicity, respectively.

Thus, there is no need for classification according to the EU Directive 67/548/EEC and to the CLP Regulation EC/1272/2008.