Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study following a standard method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Marzulli and Maibach's method based on induction period (9 applications), rest period (15 days) and challenge phase.
Marzulli F.N. and Maibach H.I. Contact allergy, predictive testing in man. Contact Dermatitis, 1976, 2, 1-17.
GLP compliance:
no
Remarks:
However, study carried out to Good Clinical Practice - GCP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
EC Number 203-919-7
EC Name 2-(2-ethoxyethoxy)ethanol
CAS Number 111-90-0
Molecular formula C6H14O3
IUPAC Name 2-(2-ethoxyethoxy)ethanol
Type of substance
Composition mono constituent substance
Origin organic
Trade names DEGEE, diethylene glycol methyl ether
- Name of test material (as cited in study report):Transcutol
- Physical state:translucent liquid
- Analytical purity:pure

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed:25
- Sex:males or females
- Age:18-70 (the year range 65-70 should not represent more than 10% of the total number of volunteers)
- Race:Caucasian
- Demographic information:Francophone volunteers, able to read the documents they were presented with and to hold to what they were explained.
- Other: the volunteers should be affiliated to a social security organisation.
Clinical history:
Exclusion criteria included certain medical conditions, pregnancy, nursing, or not able to use medically acceptable contraception, immunological deficit, background of drug intolerance, allergic background, skin disease, febrile illness, some smokers and volunteers having had or being in the course of long-term treatment, in particular with antihistamine, steroids, beta blocker collyriums, of desensitization.
Controls:
During the induction period, in parallel to the application of the test article, i.e. on the volunteer's left arm, isolation chambers alone without test article were applied at Day 1 and Day 17 under the same conditions, to act as 'negative' control.
During the challenge period, the test article were applied on the left side of the spine on the back, and the patch tests alone (without test article) were applied under the same conditions in parallel to the test articles to act as 'negative' control (on the right side of the spine).
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch:Finn chambers on Scanpor, delivered by Promedica. It is composed of an aluminium cupule 8mm in diameter covering a contact surfact of 50mm2. Each cupule is individually mounted onto an adhesive tape applied in such a manner as to exert equal pressure on all cupules. The liquid test article were put onto a disc of filter paper (7mm) previously inserted into the cupule.
- Vehicle / solvent:none
- Concentrations: as supplied
- Volume applied:0.02ml
- Testing/scoring schedule:
Induction period - 9 applications on the inside of the left arm, allocated on 3 weeks. Applications were of 48hr exposure (1st, 2nd, 4th, 5th, 7th, and 8th applications) or about 72hours (3rd and 6th applications)
Rest period - From Day 21 to Day 35, i.e. for a 15 day period
Challenge period - Single application at Day 36 on the back. Duration of exposure 48hrs

- Removal of test substance:no data
- Other:

EXAMINATIONS
- Grading/Scoring system:
During induction - Cutaneous examinations was conducted about 30minutes after removal of the patch tests of the 1st and 8th applications of the test articles, and immediately after removal of the patch tests of the 7 other applications.
At challenge - 24 and 48hrs after removal of the patch.

Special attention was paid to the reading carried out after the 1st application, in order to verify the irritative potential of the test articles applied.

- Statistical analysis:none

Results and discussion

Results of examinations:
No pathological irritation, nor significant sensitisation reaction was noted. The only reaction observed was a soaped-like effect (worn aspect of the skin) in 19 out of the 24 volunteers included in the study.

Any other information on results incl. tables

30 volunteers of both sexes were recruited and selected for the study. 25 came to the center on the day of treatment start and all were included by the Investigator. One of them (a man) abandoned the study on the 12th day.

The final 24 volunteers were 6 women and 18 men.

Applicant's summary and conclusion

Conclusions:
The substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol is an analogue of the test substance used in the study.Under these experimental conditions, 2 -(2 -ethoxyethoxy)ethanol did not induce any primary or cumulative irritation, nor any cutaneous sensitisation reaction.

Executive summary:

The substance2-(2-(2-butoxyethoxy)ethoxy)ethanolis an analogue of the test substance used in the study.

In a human volunteer insult patch test skin sensitisation study using 2 -(2 -ethoxyethoxy)ethanol, 25 healthy adult healthy volunteers were subjected to nine occlusive 48 -72hr patch applications of 0.02ml of test substance. This was followed by a resting period and a challenge patch to evaluate sensitisation potential. Under these experimental conditions, 2 -(2 -ethoxyethoxy)ethanol did not induce any primary or cumulative irritation, nor any cutaneous sensitisation reaction.