Phosphoric acid, mono- and di-C16-18-alkyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1989-07-10 to 1989-07-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read-across from GLP guideline study, tested with the source substance Aluminium dicetyl phosphate. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium dicetyl phosphate

IUPAC Name:

Aluminium dicetyl phosphate

Constituent 2

Reference substance name:

26527-54-8 (Aluminium dicetyl phosphate)

IUPAC Name:

26527-54-8 (Aluminium dicetyl phosphate)

Constituent 3

Reference substance name:

Phosphoric acid, di-hexadecyl ester, aluminum salt

IUPAC Name:

Phosphoric acid, di-hexadecyl ester, aluminum salt

Details on test material:

- Physical state: solid
- Analytical purity: 100%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 205 to 250 g
- Fasting period before study: none
- Housing: individually in metal cages with wire mesh floors,
- Diet (e.g. ad libitum): standard laboratory rodent diet (Biosure LAD 1) ad libitum
- Water (e.g. ad libitum): domestic quality potable water ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 26°C
- Humidity (%): 63% mean daily humidity
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29-06-1989 To: 24-07-1989

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsolumbar region
- % coverage: 10% of body surface, ca. 50 x 50 mm
- Type of wrap if used: treated area was covered with gauze, which was held in place by impermeable dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30-40°C), blotted dry with absorbent paper
- Time after start of exposure: 24 h after start of exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw
- For solids, paste formed: yes; moistened with distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Purity: no data

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations twice daily, weighing on day 1, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (nature, severity, approximate time of
onset and duration of each toxic sign - daily examination), dermal irritation (daily examination), body weight (day 1, 8, 15)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

none observed

Clinical signs:

other: none observed

Gross pathology:

Terminal autopsy findings were normal.

Other findings:

Sites of application of the test substance showed no irritation reactions or other dermal changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The acute lethal dermal dose to rats of Aluminium dicetyl phosphate was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

In an acute dermal toxicity study according to OECD guideline 402 performed as limit test, groups of young adult Crl:CD^R(SD) BR rats (5 male, 5 female) were dermally exposed to Aluminium dicetyl phosphate moistened with distilled water for 24 hours to 10% of body surface area at a dose of 2000 mg/kg bw.  Animals then were observed for 14 days.

 

Dermal LD50 Males and Females > 2000 mg/kg bw

     

No mortality occurred in this limit test.

No clinical signs of toxicity were observed throughout the observation period.

The skin at the application site showed no changes.

No test substance related gross pathological changes were found in any animals.