Tetradecan-1-ol, propoxylated, esters with propionic acid

Endpoint summary

Description of key information

PPG-2 myristyl ether propionate did not evoke an allergic reaction in human participants following repeated exposure to the skin of the upper back. Under the conditions of the study, it was determined that the registered substance does not possess skin sensitisation potential and, therefore, the criteria required for classification have not been met (CLP Regulation (EC) No. 1272/2008).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 19, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

other: Human Repeated Insult Patch Test (HRIPT)

Version / remarks:

Draize, J.H., Woodard, G., and Calvery, H.D. (1944). Methods for the Study of Irritation and Toxicology of Substances Applied Topically to the Skin and Mucous Membrane. Journal of Pharmacology and Experimental Therapeutics. 83, 377 - 90.

Qualifier:

equivalent or similar to guideline

Guideline:

other: Human Repeated Insult Patch Test (HRIPT)

Version / remarks:

Draize (1959). Dermal toxicity. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Texas State
Department of Health, Austin, Texas

Principles of method if other than guideline:

- Principle of test: To determine by dermal contact the primary or cumulative irritation and/or sensitisation potential of a test material
- Short description of test conditions: Fifty-one male / female human participants aged from 17 - 62 years completed the evaluation. Eight materials were examined, including PPG-2 myristyl ether propionate. Approximately 0.15 ml of each material was applied to a 1.5 x 2 inch portion of gauze, which were then applied to the upper back between the scapulae. The procedure was followed three times per week every other day (Monday, Wednesday, and Friday) for a total of ten applications. Each site was marked to ensure continuity of patch applications. After a 24-hour period, participants were instructed to remove the induction patches and evaluation of each site for erythema and/or edema was made immediately prior to re-application. Rest periods consisted of 24 hours on a Tuesday and Thursday following removal of the gauze patches and 48 hours following removal on Saturday. After a 14-day rest period from the tenth application, challenge patches were applied to the original sites and to virgin sites on the volar forearms. Each area was evaluated at 24 and 48 hours after application and the response after challenge compared to any response observed after the early induction patches
- Parameters analysed / observed: Erytheme, edema, and vosiculation and ulceration
- Status of validation / standardisation: No standardised test guideline is available. The HRIPT test has not undergone a formal validation process

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

Explanation not provided. This in vivo skin sensitisation study was carried out before the entry into force of Annex VII of REACH Regulation (EC) No 1907/2006.

Species:

other: Human

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Selection criteria: Willingness to cooperate; absence of any visible skin disease that might be confused with skin reaction from the test material; dependability and intelligence in following directions; and reading, understanding, and signing an informed consent contract
- Age at study initiation: 18 - 65 years

Route:

other: Occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.15 ml

Day(s)/duration:

Ten applications of patches consisting of a 24-hour exposure period. Applications took place on a Monday, Wednesday, and Friday, with a 24-hour rest period following Tuesday and Thursday removal, and a 48-hour rest period following Saturday removal.

Route:

other: Occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

15 ml

Day(s)/duration:

At the conclusion of a 14-day rest period following the tenth induction application, challenge patches were applied and evaluated at 24 and 48 hours after application.

No. of animals per dose:

Fifty-one

Details on study design:

TEST SITE
- Area of exposure: Upper back between the scapulae
- Coverage: 1.5 x 2 inch gauze portion
- Type of wrap: Gauze portion of a Coverlet adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: Patches were removed after 24-hours by the participants

OBSERVATION TIME POINTS: Ten observation points that occurred immediately prior to reapplication (i.e. 24 or 48 hours after end-exposure). After a 14-day rest, tested areas at the original and virgin sites were evaluated at 24 and 48 hours after challenge patch application

SCORING SYSTEM: No visible reaction - 0; mild erythema - 1+; well defined erythema - 2+; erythema and edema - 3+; erythema and edema with vosiculation and ulceration - 4+

Positive control substance(s):

no

Key result

Reading:

other: All

Group:

test chemical

Dose level:

15 ml

No. with + reactions:

0

Total no. in group:

51

Clinical observations:

No visible erythema / edema

Remarks on result:

no indication of skin sensitisation

Primary and cumulative dermal exposure to PPG-2 myristyl ether propionate did not result in erythema, edema, and/or vosiculation and ulceration over the study period. No visible reaction was observed.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study PPG-2 myristyl ether propionate did not exhibit any potential for dermal irritation and/or sensitisation in human participants and, therefore, it does not meet criteria for classification according to CLP Regulation (EC) No. 1272/2008.

Executive summary:

PPG-2 myristyl ether propionate was applied to the upper back of fifty-one human participants (male / female) between the scapulae in order to determine its irritation and sensitisation potential. A guideline was not specified in the experimental report; however, the test procedure appears to be similar to that outlined in the Human Repeated Insult Patch Test (HRIPT) by Draize et al. (1944) and Draize (1959). A concentration of 0.15 ml PPG-2 myristyl ether propionate was applied to the gauze portion (1.5 inch x 2 inch) of Coverlet adhesive dressings and applied to the skin site to form an occlusive covering. The procedure was repeated three times per week on alternating days (Monday, Wednesday, and Friday) for a total of ten applications and removed by the participants after a 24-hour exposure time. A rest period of 24 hours (Tuesday and Thursday) or 48 hours (Saturday / Sunday) occurred between the application points. Examination for erythema, edema, and/or vesiculation and ulceration was made immediately prior to re-application and an appropriate grading score assigned from 0 - 4 based on the severity of any skin lesions. Following the tenth application, a rest period consisting of 14 days was permitted. Challenge patches were applied to the original back and virgin forearm skin sites thereafter and observed at 24 and 48 hours. Across all participants during the study period, no visible reaction was observed in the ten induction exposures, nor in the later original and virgin site skin test. It was concluded that PPG-2 myristyl ether propionate is not a dermal irritant or sensitiser and that it does not require classification (CLP Regulation (EC) No. 1272/2008).

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The endpoint conclusion obtained for skin sensitisation is determined to be suitable for regulatory purpose. The study was carried out prior to the Good Laboratory Practise (GLP) regulations of 1979 (21 CFR Part 58) but followed a protocol that is considered to be similar / equivalent to the Human Repeated Insult Patch Test (HRIPT) by Draize et al. (1944) and Draize (1959). Given that the procedure was published by The Journal of Pharmacology and Experimental Therapeutics and The Association of Food and Drug Officials of the United States, Department of Health it can be considered to be a recognised standard method. The restrictions of the study are acceptable and, therefore, a Klimisch score of 2 (reliable with restrictions) has been assigned.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available