Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(hydroxyethyl) derivs.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Data on identity of the test substance are lacking; no data on batch number and composition. No data on QA or persons involved. Reference is made to a method but no details are available. No data on amount of substance used for exposure, nor exposure duration is given.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Jadassohn & Bloch

Principles of method if other than guideline:

No data available

GLP compliance:

not specified

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)

EC Number:

800-029-6

Cas Number:

1290049-56-7

Molecular formula:

Not applicable

IUPAC Name:

Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)

Test material form:

other: Liquid solution

Details on test material:

Berol TL 455 was applied as obtained from MoDo Kemie, Stenungsund, Sweden on 29-09-1971.
The product was a 20% solution of test substance ("WAS= Waschaktieve Substanz")

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed for skin irritation effects after occlusion: 60 of which 20 persons had a sensitive skin.
- Number of subjects exposed for repeated epicutaneous exposure: 10

Clinical history:

No data

Route of administration:

dermal

Details on study design:

The test substance was applied to the back and to the innerpart of the upperarm of the persons.
The exposure site was occluded with a sticking plaster.

Irritation: No data on the amount of substance applied or on the exact duration of the exposure (< 24 hours).
24 , 48 and 72 hours after exposure observations were made.

Repeated epicutaneous exposure: No data on the amount of substance applied or on the exact duration of the exposure (< 24 hours).
After an initial dermal application a waiting period of 24 hours was applied.
Then repeatedly 5 x the testsubstance was applied every 48 hours, after which the 7th (final) exposure followed a 10 days waiting period.

According to the author, severe test conditions were applied (occlusion and in damp condition).

Results and discussion

Results of examinations:

No skin irritation effects were observed 24, 48 or 72 hours after the single occluded exposure.
No skin effects were noted after the repeated exposure.

Applicant's summary and conclusion

Conclusions:

Based on the information obtained from the humans in this study and the exposure conditions, it can be concluded that the product Berol TL 455 (20% WAS) is not a skin irritant to humans and not a skin sensitiser to humans under the conditions of the test. A serious lack of data with respect to treatment and volunteers makes the conclusion rather weak.

Executive summary:

In this study human skin from volunteers was used to assess the potential of the substance Berol TL455 (20%) for irritation and sensitisation. 60 volunteers of which 20 persons with sensitive skin were tested on their back and innerpart of the upperarm for skin irritation according to the method of Jadassohn and Bloch (occluded patch). 24, 48 and 72 hours after exposure no skin reactions were noted. By multiple epicutaneous exposure, 10 persons were exposed via patches at the same spots seven times. After the first exposure, a 24 hours pauze was applied before the second till sixth exposure took place with a 48 hours application interval. Final (seventh) application was done after final pauze of 10 days. No skin reactions were observed.