Alkanoic acid and polyoxomolybdate borate alkanoate clusters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019-01-25 to 2019-04-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

dated October 9th, 2017

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate dated 27 April 2017

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 219 to 231 g prior to dosing
- Housing: During the treatment the animals were kept in individual cages. On D1, the animals were put together into their cage. The rats were kept in solid-bottomed clear polycarbonate cages with a stainles seelt mesh lid. Each cage contains dust free wood shavings which were changed at least 2 times per week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (ad libitum): ENVIGO 2016
- Water (ad libitum): tap-water from public distribution system)
- Acclimation period: at least 5 days prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled to remain within target range of 19°C to 25°C
- Humidity (%): controlled to remain within target range of 30% to 70%
- Air changes (per hr): at least 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h/12h

Administration / exposure

Type of coverage:

other: topical application under non occlusive porous gauze dressing, gauze dressing removed after 24-hour exposure period

Vehicle:

other: ethanol in liquid paraffin (2/8, w/w)

Details on dermal exposure:

Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the tes animals by clipping. At leat 10% of the ody surface was clear for the application of the test item.
Ethanol in liquid paraffin (2/8, w/w) was chosen as it produced the most suitable formulation at the requested concentration.
6.4147 g of the test item was weighted and 25.66g of the vehicle was added to obtain a preparation weighing of 3207 g. The preparation was stirred manually and by vortex to obtai a green homogeneous emulsion just before the administration.
Animals from treated group received by topical application, under non-occlusive porous gauze dressing (50 mm * 50 mm non woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic micropore adhesive tapefrom 3M), an effective dose of 2000 mg/Kg body weight administered under a volume of 10 mL/Kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed.

Duration of exposure:

24-hour exposure period

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

1 (range-finding study) + 2 (main study) female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days after dosing
* Daily examination: Systemic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. This examination focuses particularly on a list of symptoms, recorded as present of absent on the observation sheet. These observations were compared to historical data. Observations and a mortality report were carried out every day for 14 days.
* Periodical examinations: The animal were weighed on day 0 (just before adminstering the test item) then on day 2, day 7 and day 14. Wieght changes were calculated and recorded.
* Examination at the end of the test: On day 14, the animals were anesthesised with sodium pentoarbital (Dolethal). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured during the study.

Clinical signs:

other: other: No systemic clinical signs related to the administration of the test item were observed. Erythema was noted in treated animals (1/3) at 24 hours post dose. The reaction was totally reversible on day 3. Black coloration not preventing quotation of e

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat.
The test item does not have to be classified in accordance with the Regulation EC n° 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.