Potassium hexadecyl hydrogen phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-06-01 until 1987-06-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Paragraph 81-2: "Acute dermal toxicity study"; U.S. Environmental Protection Agency, Office of Pesticide and Toxic Substances, Washington, D.C., November, 1982

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hexadecyl hydrogen phosphate

EC Number:

242-768-1

EC Name:

Potassium hexadecyl hydrogen phosphate

Cas Number:

19035-79-1

Molecular formula:

C16H35O4P.K

IUPAC Name:

potassium hexadecyl hydrogen phosphate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: Ibm: RORO (SPF), also known as Fü-albino SPF rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: about 8 weeks
- Weight at study initiation: female 162-186 g; male 244-278 g
- Housing: The rats were individually kept
- Diet: NAFAG standard rat maintenance diet, No. 850 (cubic), ad libitum
- Water : tap water, ad libitum
- Acclimatisation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 45-65 %
- Air changes: air-conditioned room
- Photoperiod : 12/12 hrs dark / hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: the test article was moistened with water

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: about 10 % of the total body surface area
- Type of wrap if used: The application site of all rats was covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin was cleaned with lukewarm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex

Details on study design:

- Duration of observation period following administration: 16 days
- Frequency of observations and weighing: weighing recorded on days 1(immediately before treatment), 5, 9, 12, and 17. Clinical signs were examined every day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (behaviour, vivacity, signs of injury, local skin reactions, signs of sickness and abnormality), body weight, and in autopsy a gross examination was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: After removing of occlusive dressing, reddish maculae became visible on the application site of 3 female rats. These reddish maculae had disappeared at week 2 of the observation period. No other incompatibility reactions appeared.

Gross pathology:

With the exception of 2 bulbous nodules in the left-hand uterus horn in 1 female rat, which were formed by proliferative processes and considered to be accidental findings without relation to treatment, no gross findings were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Five male and 5 female Fü-albino SPF rats were randomly selected for an acute dermal toxicity study. The animals were treated by dermal application of a single dose of 2000 mg/kg of the test substance moistened with water to a shaven area of skin (approximately 10% of the total body surface) on their backs. The application site of all rats was covered with an occlusive dressing which was fixed with elastic adhesive bandages. After 24 hours, the test item was removed with lukewarm water and the skin was inspected whether the treatment caused skin reactions. During 16 days, all animals were observed for toxic signs including mortality and body weight changes. At the end of the study, all rats were examined for gross lesions. No deaths occurred. The LD50 value determined was greater than 2000 mg/kg bw. With the exception of reddish maculae on the application site of 3 female rats, no incompatibility reactions appeared. No effect on the body weight development was observed. No treatment-related gross lesions were observed.