1,3-Benzenedicarboxamide, 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-, hydrochloride (1:1)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1995-March, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study described in this report was conducted in compliance with the following Good Laboratory Practice Standards: Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

ABA Hydrochloride

IUPAC Name:

ABA Hydrochloride

In vivo test system

Test animals

Species:

guinea pig

Strain:

Peruvian

Sex:

male

Study design: in vivo (LLNA)

Vehicle:

other: Water

Concentration:

Concentration of test material and vehicle used at induction:
intradermal 5% in bi-distilled water

No. of animals per dose:

Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (LLNA)

Results

Parameter:

other: See remark

Value:

0

Remarks on result:

other: No adverse effects on any of the test subjects

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 % Signs of irritation during induction: none Evidence of sensitisation of each challenge concentration: none

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

In this study none of the animals of the test group were observed with positive skin reactions after the treatment with a non-irritant test substance concentration of 50% in bi-distilled water. No skin reactions were observed in the control group.
A response of at least 30% positive animals is considered positive “R43”: may cause sensitization by skin contact according to the “Commision Directive 93/21/EEC, April 27, 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances”.
Therefore, the test article ABA-HCl at a concentration of 50% in bi-distilled water is considered to be a non-sensitizer when tested under the described test conditions.

Executive summary:

The purpose of this skin sensitizing study was to assess the possible allergenic potential of ABA_HCl to albino guinea pigs. The maximization-test of B. Magnusson and A.M. Kligmann (1969) was used. Twenty male animals of the test group were induced intradermally once a week in the first week and epidermally once a week in the second week with ABA-HCl at 5% and 50% in bi-distilled water, respectively. Two weeks after the epidermal induction application the animals were challenged with the vehicle bi-distilled water and the highest non-irritating test article concentration of 50% in bi-distilled water. The animals of the control group were induced with the bi-distilled water only and treated once at challenge with bi-distilled water and ABA-HCl at 50% in bi-distilled water ERYTHEMATEOUS REACTIONS AFTER THE CHALLENGE PROCEDURE After 24 hrs After 48 hrs Positive/total Positive/total % positive total % positive total CONTROL GROUP   ABA-HCl (left flank) 0/10 ---- 0 0/10 ----- 0   Bi-distilled water only (right flank) 0/10 ----- 0 0/10 ----- 0   TEST GROUP   ABA-HCl (left flank) 0/20 ---- 0 0/20 ---- 0   Bi-distilled water only (right flank) 0/20 ----- 0 0/20 ---- 0   No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred.