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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Details on oral exposure:
singel dose
Doses:
dose of 2000 mg/kg body weight
No. of animals per sex per dose:
6
Control animals:
not specified
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred during the study
Clinical signs:
other: No clinical signs related to the administration of the test item were observed.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item ADDUKT TI65-MXDA is higher than 5000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline n°423. 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, the test item ADDUKT TI65-MXDA must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal work and hazard statement are required.
Executive summary:

The test item ADDUKT TI65-MXDA was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline N°423 dated December 17th,2001 and the test method B.1 tris of the Directive N°2004/73/EC. No mortality occurred during the study. No 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 macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50of the test item ADDUKT TI65-MXDA is higher than 5000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline N°423. 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, the test item ADDUKT TI65-MXDA must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal work and hazard statement are required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
Version / remarks:
SEPA chemical testing methods Editorial Board. The Guidelines for Testing of Chemicals (Health Effects part) [M]. China Environmental Science Press. 2013 : 258-276
Deviations:
not specified
GLP compliance:
no
Test type:
other: infection method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The rats reared in stainless steel wire cages (500W x 350D x 200H mm), 5 animals were housed in a cage, every single gender in a cage Drinking water and feed were provided ad libitum. The animal rooms were cleaned once a day and autoclaved aluminum trays were replaced three times a week. During the test period, the animal room kept temperature at 21.9-23.5 'C, humidity in 51.9-59.6 %. Pressure between room and corridor was greater than 10 Pa, ventilation was more than 15 times per hour, and lighting period was 12 hours per day (8:00-20:00).
Route of administration:
inhalation: dust
Type of inhalation exposure:
other: nose and mouth
Vehicle:
air
Duration of exposure:
ca. 4 h
Concentrations:
limit test at 5.0 mg/L
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
10 rats (5 ♂ and 5 ♀) were employed in acute inhalation toxicity test. The test animals were weighed before exposure and placed in the container. Rats were infected at the dose of 5.0 mg/L after balancing test concentration for 4 hours.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No obvious toxicity and no death of test rats were showed during test, Observed and recorded during the test.
Clinical signs:
other: No obvious toxicity of test rats were observed during exposure.
Body weight:
Body weights of test rats increased significantly during the experimental period.
Gross pathology:
No obvious abnormalities of test rats induced by ADDUKT TI180-MXDA were observed by necropsy at the end of study period.
Other findings:
No obvious toxicity of test rats were observed during exposure.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance ADDUKT TI180-MXDA (batch number: #VPE 1724/18) inhalation infection at the dose of 5.0 mg/L for 4 hours observed no obvious toxicities. No obvious abnormalities of test rats induced by ADDUKT TI180-MXDA were observed by necropsy at the end of study period. The suction LC50 of test substance ADDUKT TI180-MXDA is greater than 5.0 mg/L. Under the present experimental conditions, rats were observed no obvious toxicities after infecting with the test substance ADDUKT TI180-MXDA (batch number: #VPE 1724/18) at the dose of 5.0 mg/L. The suction LC50 of ADDUKT TI180-MXDA is greater than 5.0 mg/L.
Executive summary:

Purpose:

To evaluate the toxic effects and reversibility of ADDUKT TI180-MXDA by observing functional and morphological changes after inhalation administration of ADDUKT TI180-MXDA at dose of 5.0 mg/L to SD rats. This test will also provide information for both the acute toxicity classification and sub-chronic exposure doses.

 

Method:

10 rats (5♂and 5♀) were employed in acute inhalation toxicity test. The test animals were weighed before exposure and placed in the container. Rats were infected at the dose of 5.0 mg/L after balancing test concentration for 4 hours. Animals were daily observed for 14 days. All observations from individual rat were systematically recorded. Body weight of each animal was recorded prior to administration (recorded as d0), d1, d3, d7 and d14 respectively. All test animals should be subjected to gross necropsy. The observation of heart, lung, kidney, Iiver, spleen, gastrointestinal tract and other organs were performed to make sure whether there were any hemorrhage and edema.

 

Result:

No obvious toxicities were observed on test rats infected by ADDUKT TI180-MXDA at the dose of 5.0 mg/L. Body weights increased significantly during the experimental period. No obvious abnormalities of test rats induced by ADDUKT

TI180-MXDA were observed by necropsy at the end of study period.

 

Conclusion:

Under the present experimental conditions, rats were observed no obvious toxicities after infecting with the test substance ADDUKT TI180-MXDA (batch number: #VPE 1724/18) at the dose of 5.0 mg/L. The suction LC50of ADDUKT TI180-MXDA is greater than 5.0 mg/L.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free weed shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively. The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Type of coverage:
other: gauze dressings
Vehicle:
other: dimethylsulfoxide
Details on dermal exposure:
Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item Addukt TI 65 - MXDA. 2.0053 g and 4.0012 g of the test item was weighed and dimethylsulfoxide was added to a 10 and 20 mL volumetric flask, respectively. The preparation was magnetically stirred and heated at around 50°C to obtain a whitish to yellow solution just before the administration. The preparation was administered under a volume of 10 mL/kg body weight, during 24 hours. After 24-hours exposure period, the gauze dressings were removed and the treated areas were rinsed with distilled water and paraffin oil.
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
yes
Remarks:
control group referred to historical values
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no
Clinical signs:
other: No systemic clinical signs related to the administration of the test item were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Addukt TI 65 - MXDA is higher than 2000 mg/kg body weight by dermal route in the rat. 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, the test item Addukt TI 65 - MXDA does not have to be classified. 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.
Executive summary:

The test item Addukt TI 65 - MXDA was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 402 dated February 24th, 1987 and the test method B.3 of the Council regulation No. 440/2008 of 30 May 2008. No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed.

Cutaneous reactions (erythema and dryness) were noted from day 2 in all animals and were totally reversible on day 8. A white coloration of the treated site was noted from 24 hours post-dose in all animals and was totally reversible on day 2. The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test item Addukt TI 65 - MXDA is higher than 2000 mg/kg body

weight by dermal route in the rat. 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, the test item Addukt TI 65 - MXDA does not have to be classified. 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification