Phosphoric acid, mono- and di-C11-14 (linear and branched) 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:

1985-08-21 to 1985-09-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read-across from guideline study, tested with the source substance Dihexadecyl 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:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

ten male and ten female rats were used

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: notification No. 118 of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 15 February 1984 Toxicity Test Guideline

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dihexadecyl phosphate 

IUPAC Name:

Dihexadecyl phosphate 

Constituent 2

Reference substance name:

2197-63-9 (Dihexadecyl phosphate )

IUPAC Name:

2197-63-9 (Dihexadecyl phosphate )

Details on test material:

- Physical state: solid (white flakes)
- Analytical purity: not given in test report, but according to supplier 100%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauma UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: eight to eleven weeks
- Weight at study initiation: 200 - 256 g
- Fasting period before study: N/A
- Housing: individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 23°C
- Humidity (%): 63% mean
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15.08.1985 To: 04.09.1985

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
One day prior to treatment hair was removed with electric clippers. No shaving or chemical depilation was used.

- Area of exposure: dorsolumbar region 5x5 cm
- % coverage: 10%
- Type of wrap if used: gauze which was held in place with an impermeable dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: warm (30°-40°C) water
- Time after start of exposure: 24-h

TEST MATERIAL - Amount(s) applied (volume or weight with unit): 2.0 g/kg
- Constant volume or concentration used: yes 2.5 mL/kg
- For solids, paste formed: yes 80% w/v paste in distilled water

VEHICLE A
similar group of twenty rats (ten males and ten females) was dosed with distilled water at the same dose volume as the test group and served as controls.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : twice daily
- weighting: day 1 (day of dosing), 4, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

There were no mortalities following a single dermal dose of Dihexadecyl phosphate at 2000 mg/kg bodyweight to a group of ten male and ten female rats.

Clinical signs:

other: There were no signs of toxicity following treatment in either test or control rats. There were no dermal reactions at the site of application in any of the test (2000 mg/kg Dihexadecyl phosphate) or control (distilled water) rats.

Gross pathology:

Terminal autopsy findings were normal.

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:

On the basis of the results obtained after a single dermal administration in rats, the dermal LD50 of the test article Dihexadecyl phosphate was determined to be > 2000 mg/kg bw. No significant clinical signs, changes in body weight or gross patological findings were observed.

Executive summary:

In an acute dermal toxicity study performed comparable to a limit test (OECD guideline 402), 10 female and 10 male young adult rats were dermally exposed to Dihexadecyl phosphate 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 occured 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.