Dimethyl octadecylphosphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Adequacy of study:

supporting study

Study period:

1971-12-02 to 1972-01-05

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Non-GLP/non-guideline study (this study was conducted in the United States prior to issue of the OPPTS harmonised Test Guidelines). The exposure period was 24 hours (rather than 4 hours as specified in OECD Guideline 404), the result is therefore not considered to be valid for the purposes of classification. In addition, no consideration was given to a possible effect on the skin from the administration of the test substance which was warmed to 46oC.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

DMOP was applied to the clipped intact skin of New Zealand White male and female rabbits under a one inch by one inch square patch which was held in place by an occlusive dressing for an exposure period of 24 hours. Observations were made over a period of seven days for irritation and scored according to the method of Draize, Woodard and Calvery.

GLP compliance:

no

Remarks:

The study was performed in 1972.

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl octadecylphosphonate

EC Number:

246-904-0

EC Name:

Dimethyl octadecylphosphonate

Cas Number:

25371-54-4

Molecular formula:

C20H43O3P

IUPAC Name:

dimethyl octadecylphosphonate

Constituent 2

Reference substance name:

M-5925

IUPAC Name:

M-5925

Test material form:

other: waxy solid

Details on test material:

Test Item Identification: M-5925. Test substance adminstered undiluted, warmed to 115°F (46°C), to liquefy.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

3 animals (2 ♂ and 1 ♀)

Details on study design:

0.5 ml of undiluted Dimethyl octadecylphosphonate (DMOP) was applied to the clipped intact skin of New Zealand White male and female rabbits.

TEST SITE
- Area of exposure: 1inch × 1 inch gauze patches
- % coverage: not reported
- Type of wrap if used: the patches were held in place with adhesive tape. The trunk of each animal was wrapped with plastic strips, to retard evaporation and avoid contamination for the 24 hour exposure period

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable

SCORING SYSTEM: Observations were made over a period of seven days for irritation and scored according to the method of Draize, Woodard and Calvery.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 hours

Score:

8

Max. score:

8

Reversibility:

not fully reversible within: 168 hours

Remarks on result:

other: The exposure period was 24 hours (rather than 4 hours as specified in OECD Guideline 404), the result is therefore not considered to be valid for the purposes of classification.

Any other information on results incl. tables

Animal Number/Sex	1 Hour	24 hours	48 hours	72 hours	120 hours	168 hours
1- Male	0	7	8	8	8	8
2 – Female	0	6	8	8	8	8
3 - Male	0	7	8	8	8	8
Average	0	6.6	8	8	8	8

Applicant's summary and conclusion

Interpretation of results:

other: The result is not considered to be valid for the purposes of classification since the exposure period was 24 hours rather than 4 hours as specified in OECD Guideline 404.

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

It was concluded by the author that DMOP was a "corrosive irritant", however the test (conducted in 1972) was not performed to GLP or test guidelines and the exposure period was 24 hours rather than 4 hours as specified in OECD Test Guideline 404. The result is therefore not considered to be valid for the purposes of classification.

Executive summary:

0.5 ml of undiluted Dimethyl octadecylphosphonate (DMOP) was applied to the clipped intact skin of New Zealand white male and female rabbits under a one inch by one inch square patch, two single layers thick. The patches were held in place with adhesive tape. The trunk of each animal was wrapped with plastic strips, to retard evaporation and avoid contamination for the 24 hour exposure period. Observations were made over a period of seven days for irritation and scored according to the method of Draize, Woodard and Calvery.

It was concluded by the author that DMOP was a "corrosive irritant", however the test (conducted in 1972) was not performed to GLP or test guidlines and the exposure period was 24 hours rather than 4 hours as specified in OECD Test Guideline 404. The result is therefore not considered to be valid for the purposes of classification.