Registration Dossier

Administrative data

Description of key information

ACUTE ORAL TOXICITY
The study was performed according to OECD guideline No. 423 and EU method B.1tris in a GLP certified testing facility. The test was performed as limit test with a single oral dose of 2000 mg/kg bw of 400160. No effects were observed. The LD50 of 400160 is higher than 2000 mg/kg bw by oral route in the rat.
ACUTE DERMAL TOXICITY
The acute dermal toxicity study with 400160 was performed according to OECD guideline 402 and EU method B.3 in a GLP certified testing facility. The test was performed as limit test with a single dose of 2000 mg/kg bw. No effects were observed. The LD50 of 400160 is higher than 2000 mg/kg bw by dermal route in the rat.
ACUTE INHALATION TOXICITY
The acute inhalation toxicity test was waived as acute toxicity data is available for the oral and dermal route. Considering manufacturing and known uses the exposure by inhalation has not to be tested.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study was performed according to OECD guideline No. 423 and EU method B.1tris in a GLP certified testing facility. The database is considered to be reliable (Klimisch score 1).

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
Quality of whole database:
The study was performed according to OECD guideline 402 and EU method B.3 in a GLP certified testing facility. The database is considered to be reliable (Klimisch score 1).

Additional information

ACUTE ORAL TOXICTY

In an acute oral toxicity study 2 groups of 8-week old female Sprague Dawley (SPF Caw) (n=6) were given a single oral dose of 400160 at a dose of 2000 mg/kg b.w. and observed for 14 days.

No mortality or any other clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The microscopic examination of the animals at the end of the study did not reveal treatment-related changes.

The test was performed as limit test.

Oral LD50 (females) >2000 mg/kg b.w.

400160 is of low toxicity based on the LD50 in female rats.

 

ACUTE DERMAL TOXICITY

The acute dermal toxicity study of 400160 was performed as limit test. Groups of young adult Sprague Dawley rats (5 male/5 female) were dermally exposed to 400160 for 24 h to at least 10% of body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.

No mortality occurred during the study. No systemic clinical sign related to the administration of the test item was observed. The body weight evolution of the animals remained normal throughout the study. The macroscopically examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of 400160 is higher than 2000 mg/kg bw by dermal route in the rat.

 

ACUTE INHALATION TOXICITY

According to REACH Annex VIII, section 8.5., column 2, acute toxicity data should be presented for the oral route and at least for one additional route (i.e. dermal or inhalative). The choice for this second route shall depend on the nature of the substance and the likely route of human exposure.

The inhalative route is not considered to be relevant for 400160, as the vapour pressure of this compound is low (see section 4.6 of this IUCLID dataset) and exposure to aerosols, particles, or droplets of an inhalable size is unlikely. Moreover, the conditions used in the manufacturing and formulation process of 400160 do not suggest a significant exposure via air.

Therefore, the acute toxicity data available for the oral and dermal route are regarded as sufficient and performing and additional acute inhalative toxicity study is not necessary.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – inhalation endpoint
Acute toxicity data is available for the oral and dermal route. An additional acute inhalative toxicity study is not necessary.
 

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Based on the result of the oral toxicity study, it can be concluded that 400160 has a very low toxicity to rats after a single oral administration. According to the current EU-CLP criteria, this compound cannot be classified with respect to acute oral toxicity, as the LD50value (>2000 mg/kg bw) exceed the range given for all three categories of the EU-CLP system. No risk phrase is required.

Based on the results of the dermal toxicity study (LD50 >2000 mg/kg bw) it can be concluded that 400160 does not have to be classified according to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified. No signal word or hazard statement is required.