Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

From December 28th, 1973 to February 2, 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data have been obtained from a study on a substance with structural similarity. The study has been performed not in accord to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Repeated insult patch test

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Lanoline Alcohol

IUPAC Name:

Lanoline Alcohol

Test material form:

other: solid and liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

42 females; 8 males;
Ranging from 15 years to 69 years

Controls:

yes

Route of administration:

dermal

Details on study design:

42 Females; 8 Males;
Ranging from 15 years to 69 years
TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: directly to the skin and with a gauze patches;
- Description of patch: air-light with "non-allergic" tape;
- Test site: arms or forearms (constant for the same individuals);
- Volume applied: 0.5 ml and 0.5 g
- Time of contact/application/method:
1° application (for 48 hours);
One day of rest;
2° application (for 24 hours).
10 consecutive applications followed;
10- 14 days of rest;
Last application (for 48 hours)
EXAMINATIONS
- Grading/Scoring system: erythema (intensity and area involved); edema (elevation of the skin with respect to the contour of the unaffected normal skin);
- Observations: during the 10 days
TYPES OF REACTION:
-Primary Irritation: local reaction. These irritant are able to exceed the protective resistance threshold of the skin on one application;
- "Fatiguing": not considered incidents of sensitization. It is not a condition whereby the skin has lost its significant normal phsycological function, rather it is a subtle change where the skin loses its original resistance to the repeated application of a material.
These irritants produce skin reactions by a summation of insults of a sub-threshold intensity.
- Sensitization: the skin can react after a period of rest giving a specific response of the entire body. These irritants are detected only after the skin has previously been exposed to the materials.

Results and discussion

Results of examinations:

Total points scored:
P.I.(primary irritation)= 8 (1 evaluation)
P.I.(primary irritation)= from 0.0 to 1.0 and 8.0
Most of the test materials based on lanoline alcohol (7) did not produce primary irritation. 2 materials produced from no irritation to mild and severe primary irritation. One of the material based on lanoline alcohol affected 29 subjects.

F (fatiguing)= 72 (9 evaluations)
Most of the test materials (7) did not produce "fatiguing".
Three materials based on lanoline alcohol produced "fatiguing" to many subjects.

S (sensitization)=
Original site: 8 (1 evaluation)
Virgin site: 8 (1 evaluation)
Most of the test material based on lanoline alcohol (8) are considered not sensitizer.
One material produced moderate sensitization in one subject (scoring 2.2).
One material produced mild sensitization (0.3-1.5)

Any other information on results incl. tables

Percentage variation may frequently occur from group to group at various geographical locations. Climate and temperature are additional factors occasionally causing percentage variation in repeated insult patch test results.

Applicant's summary and conclusion

Conclusions:

Most of the test materials based on lanoline alcohol (7) did not produce primary irritation. 2 materials produced from no irritation to mild and severe primary irritation. One of the material based on lanoline alcohol affected 29 subjects.

Most of the test materials (7) did not produce "fatiguing".
Three materials based on lanoline alcohol produced "fatiguing" to many subjects.

Most of the test material based on lanoline alcohol (7) are considered not sensitizer.
Two materials produced moderate sensitization and mild sensitization in one subject, respectively.

Executive summary:

A repeated insult patch test (epicutaneous test) was performed to humans.

0.5 ml and 0.5 g of different products based on lanoline alcohol were directly applied to the skin and with a gauze patches on arms or forearms (constant for the same individuals).

The method consisted in 1° application (for 48 hours); one day of rest; 2° application (for 24 hours); 10 consecutive applications; 10- 14 days of rest; last application (for 48 hours).

Erythema (intensity and area involved) and edema (elevation of the skin with respect to the control of the unaffected normal skin) were observed during the 10 days.

The types of reactions recorded were:

Primary irritation, "fatiguing” (not considered incidents of sensitization) and sensitization.

Most of the test materials based on Lanoline Alcohol (7) did not produce primary irritation.

2 materials produced no irritation, mild and severe primary irritation.

One of the material based on lanoline alcohol affected 29 subjects.

7 the test materials did not produce "fatiguing".

Three materials based on lanoline alcohol produced "fatiguing" to many subjects.

Most of the test materials based on lanoline alcohol (7) are considered not sensitizer.

Two materials produced moderate sensitization and mild sensitization in one subject, respectively.

It has to be underlined that percentage variation may frequently occur from group to group at various geographical locations. Climate and temperature are additional factors occasionally causing percentage variation in repeated insult patch test results.