Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
September 12, 1990 - October 18, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline followed. Study is acceptable as basic data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: HRIPT test
Principles of method if other than guideline:
A Human Repeated Insult Patch Test (HRIPT) was conducted to assess the sensitising properties of cashmeran in humans.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):
- Molecular formula: C14H22O
- Molecular weight: 206.3
- Physical state: translucent liquid


Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 53
- Sex: 9 males and 44 females
- Age: ranging from 19 to 65 years
- Race: no data
- Demographic information: no data
- Other: subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: the 9 repeated insult (occlusive) patch test (9 RIPT)

ADMINISTRATION: INDUCTION PHASE
- Type of application: occlusive patch
- Description of patch: Parke-Davis Readi-Bandage
- Vehicle / solvent: test substance 4.0% in Alcohol SD 39C, volatilized at least 30 minutes on the patch prior to application.
- Concentrations: 4.0%
- Volume applied: 0.2 ml
- Testing/scoring schedule: rest period after removal: on Tuesday and Thursday: 24h, on Saturday: 48h, on Monday and Wednesday: 24h, on Friday: 48h.
Test site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine application of the test article had been made.
- Removal of test substance: 24 hours after application
- Other: if a subject developed a positive reaction of a 2-level erythema or greater during the induction phase or if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred at the new site, no further applications would be made.

ADMINISTRATION: CHALLENGE PHASE
- Rest period after induction: 10 to 21 days
- Type of application: previously unpatched test site (occlusive)
- Testing/scoring schedule: test site was scored 24 and 48h after application

EXAMINATIONS
- Grading/Scoring system: according to a 6-point scale:
0 = no evidence of any effect
1 = barely perceptible
2 = moderate
3 = marked
4 = severe
accompanying oedema was recorded with an "e"
- Statistical analysis: no data

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: a single, transient, barely perceptible non-specific patch test response was observed on 1/48 subjects during the induction phase of the study.

Any other information on results incl. tables

A total of 48 subjects completed the study. A single, transient, barely perceptible non-specific response was observed in one of the subjects. None of the other subject showed any response.

Applicant's summary and conclusion

Conclusions:
In a Human Repeated Insult Patch Test (HRIPT), cashmeran did not induce irritant or allergic contact dermatitis in human subject under the conditions of this test. According to the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008/EC, Cashmeran does not have to be classified as sensitizing to the skin.
Executive summary:

To determine the irritation and/or sensitization potential of Cashmeran, a repeated insult (occlusive) patch test was performed in 53 healthy volunteers. 4.0% of test substance in Alcohol SD 39C was applied to the back of each subject. After a rest period of 10 to 21 days, the challenge patch was applied to a previously unpatched site and scored 24 and 48 hours after application. A total of 48 volunteers completed the study. A single, barely perceptible non-specific response was observed on 1/48 subjects. No other effects were observed.

According to the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008/EC, Cashmeran does not have to be classified as sensitizing to the skin.