Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
13 Jan - 24 Jan 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Well documented GCP-study which meets basic scientific principles. No purity reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Human skin irritation study after single dermal application (single patch test).
GLP compliance:
no
Remarks:
, but compliant to GCP

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylene dinonanoate
EC Number:
255-350-9
EC Name:
Propylene dinonanoate
Cas Number:
41395-83-9
Molecular formula:
C21H40O4
IUPAC Name:
propylene dinonanoate

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 10
- Sex: female
- Age: 19-41
- Weight: 46-72 kg
- Race: Caucasian
- Social conditions: Volunteers able to justify of a fixed abode
- Intelligence quotient: Francophone volunteers, able to read the documents they were presented with and to hold to what they were explained.
- Social cover: The volunteers should be affiliated to a social security organisation.

EXCLUSION CRITERIA
- Volunteers who did not respect article L 209-17, law of 20 December 1988.
- Volunteers who participated in a test for the verification of the good cutaneous or peri-ocular local tolerance during the four last weeks and/or to active sensitisation type studies during the last six months.
- Volunteers who refused to sign the informed consent statement.
- Female volunteers, either pregnant or nursing mothers, or not using medically acceptable contraceptive methods.
- Volunteers having undergone organ excision (kidney, lung, spleen, liver), an organ transplant, a skull concussion with loss of consciousness since less than 5 years or with present after-effects.

Volunteers having:
- the following disorders: cardiovascular, pulmonar, digestive, neurologic, psychiatric, genital, haematological, endocrine, having a redhibitory aspect for the study concerned;
- an immunological deficit;
- a background of drug intolerance (local or general anaesthetics), and intolerance to cosmetics, to body hygiene or domestic products, to clothes, to products used at work such as cellophane, rubber (gloves, glues, adhesive tapes), nickel, aluminium;
- an allergic background: asthma, periodic spasmodic rhinitis;
- a skin disease, and in particular: dermographism, urticaria, edema, eczema, recurrent herpes, herpes zoster having erupted less than three months before, pityriasis versicolor, common acne with a sudden rise of inflammation or nordular or kystic acne, psoriasis, ichtyosis , lichen planus, chronic lupus erythematodis, cheloid scars, pigmentary disorders (vitiligo, chloasma, multiple lentigines, numerous or congenital nevi, especially if they are of large size), hyperhidrosis, dorsal hyperpilosity, important perspiration;
- a febrile illness: more than 24 hours of fever within the 6 days prior to the first application of the test article.

- Volunteers having had or being in the course of a long-term treatment, in particular with antihistamine, steroids, beta blocker.
- Volunteers who recently suffered from insolation, or having followed heliotherapy during the month preceding the study.
- Volunteers smoking more than 10 cigarettes a day and not accepting restriction of their tobacco consumption during two days prior to the start of the study and throughout the whole study.
Ethical approval:
confirmed, but no further information available
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
0.02 mL of the test substance (as supplied) were applied on the back, on a surface of about 50 mm², on a filter paper and were occlusively covered with a "Finn Chamber" (aluminium disc) and held in place with an adhesive tape. The test article was applied only once. After an exposure of 48 h, patches were removed and substantial amount of remaining test material was removed using a hydrophilic pad. Concomitantly, chambers without test substance were applied as "negative" controls.
Examinations:
Cutaneous macroscopic examinations was performed about 30 minutes after patch removal.

Results and discussion

Clinical signs:
No reaction of pathological irritation and cutaneous intolerance were noted. No subordinate effects were observed.
Results of examinations:
SKIN EXAMINATION
No skin reactions were observed in the study in any of the 10 volunteers.

Applicant's summary and conclusion

Conclusions:
The single epicutaneous application of the test substance under occlusive conditions for 48 h was well tolerated in healthy volunteers. Therefore, no indication for skin irritation was found.