[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26. April - 23. July 2019

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)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Residual solvent: 43.1 % w/w

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6-08697-43
- Expiration date of the lot/batch: 27.09.2022

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (20 ± 5 °C)
- Stability under test conditions: not stated

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 228 - 239 g
- Fasting period before study: no
- Housing: 1-3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving.
The required amount of undiluted test item (according to the body weight and dose and corrected by factor 1.757) was applied directly on the shaved skin of the back uniformly on an area approximately 10 % of a total body surface area. The test item was held in contact with the skin by using semiocclusive dressing with non-irritating tape throughout the 24-hours exposure period. At the end of the exposure period, any residuals of the test item were removed by using lukewarm water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Animals were observed individually immediately after the application of the test item and then 0.5,
1, 2, 4 and 6 hours later. Each animal was inspected daily for the next 14 days.
Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory,
circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern.
Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep
and coma. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of the test
item using the Draize criteria

Statistics:

none

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

no mortalitity occured

Clinical signs:

other: no signs of intoxication, change of health, nor any adverse reactions during 14-days observation period

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic changes were noticed.

Other findings:

The test item did not cause any changes on the skin of the test animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Reaction mass of potassium sodium phosphotartrate and potassium sodium
tartrate and potassium sodium ortho-phosphate (aqueous solution) is greater than 2000 mg/kg body
weight after single dermal application to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item Reaction mass of
potassium sodium phosphotartrate and potassium sodium tartrate and potassium sodium orthophosphate (aqueous solution) when applied as a single dermal dose to Wistar rats. The procedure
according to OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure was used.
Test item information were available, a limit dose of 2000 mg/kg body weight was used as starting
dose. One female was dosed. Test item-related mortality was not observed during 48 hours. Based on
the outcome in the dose-range finding study, the main study was conducted with 2 further animals to
confirm the classification outcome. A total of three female rats were dosed with a limit dose of 2000
mg/kg body weight.
The test item Reaction mass of potassium sodium phosphotartrate and potassium sodium tartrate and
potassium sodium ortho-phosphate (aqueous solution) applied to 3 females at a limit dose of 2000
mg/kg body weight did not cause death. Mildly increase of the body weight of animals was observed.
No signs of intoxication, change of health, nor any other adverse reactions during 14-days observation
period was observed. The test item did not cause any changes on the skin of the test animals. During
necropsy, no macroscopic findings were observed.
The LD50of the test item Reaction mass of potassium sodium phosphotartrate and potassium sodium
tartrate and potassium sodium ortho-phosphate (aqueous solution) is greater than 2000 mg/kg body
weight after single dermal application to Wistar rats.
Based on OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure it can be
concluded, that the test item Reaction mass of potassium sodium phosphotartrate and potassium
sodium tartrate and potassium sodium ortho-phosphate (aqueous solution) according to the Globally
Harmonised System can be classified in Category 5/Unclassified after single dermal application to
Wistar rats.