Hydroxyoctadecanoic acid, monoester with glycerol

Exposure related observations in humans: other data

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This is a valid scientific study examining the dermal irritation of the substance in 106 human volunteers

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Skin irritation (occlusive patch testing) for 48 hours in human volunteers.

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

Castor oil (CAS 8001-79-4), lot #L-5G30-01, was obtained from Cas Chemical, Inc., Bayonne, NJ. (now owned by Vertellus LLC). Purity analysis indicated that it was consistent with the USP specifications and the reported composition for castor oil: Analysis was conducted by Midwest Research Institute (MRI), in Kansas City, MO, utilizing infrared, UV/Vis and NMR spectroscopy, Karl Fischer water analysis, TLC and HPLC, and a battery of USP standard analyses for castor oil.

Method

Ethical approval:

not specified

Details on study design:

Selection of panelists was based on the following criteria:
a) willingness to participate in the study.
b) dependability and ability to read and understand instructions.
c) absence of any physical and dermatological condition which would preclude application of the test material.
d) Reading, understanding and signing an informed consent contract. In the case of minors, parental consent was obtained.

Exposure assessment:

not specified

Details on exposure:

Either the inner aspect of the upper arm or the back, according to the panelist's preference, was designated as the site of test material contact. A small amount of the product was dropped or placed on a 2 square cm piece of Webril (R)( Kendall) non woven cotton fabric and held in place with Blenderm (3M) occlusive tape. This was applied to the contact site and left in place for 48 hours. At the end of this period, the patch was removed and the degree of dermal response was recorded using the scale of Schwartz-Peck.

Results and discussion

Results:

Of 100 human volunteers tested with Castor oil AA USP, a skin reaction was elicited from 1 panelist. This was a 2+ reaction (well defined erythema), which subsided to 1+ in 24 hours. Castor Oil AA USP is evaluated as non-irritating.

Applicant's summary and conclusion

Conclusions:

Of 100 human volunteers patch tested with Castor oil AA USP, only one panelist had a mild reaction. The study on Castor OIl AA USP is evaluated as negative (non-irritating).