Reaction mass of 2-[[[2-[(2-aminoethyl)amino]ethyl]amino]carbonyl]-benzoic acid and 2,2' -[iminobis(2,1-ethanediyliminocarbonyl)]bis-benzoic acid and 7,8,9,10,11,12,20,21,22,23,24,25-dodecahydrodibenzo[i,t] [1,4,7,12,15,18] hexaazacyclodocosine-5,13,18,26(6H,19H)-tetrone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The study was performed to determine to possibility of the test item to induce skin sensitisation.
50 caucasian Humans (25 males and 25 females ) were used to performed the experiment.
The test material was evaluated at a concentration of 10% in 3% methyl cellulose.
The series of 9 induction patches was applied .
Based on the incidence and severity of the reactions, the test material will be considered as sensitising or not to Human skin.

GLP compliance:

no

Type of study:

patch test

Test material

Test material information

Constituent 1

Reference substance name:

2-({2-[(2-aminoethyl)amino]ethyl}carbamoyl)benzoic acid; 2-{[2-({2-[(2-carboxyphenyl)formamido]ethyl}amino)ethyl]carbamoyl}benzoic acid; 3,6,9,18,21,24-hexaazatricyclo[24.4.0.0¹¹,¹⁶]triaconta-1(30),11,13,15,26,28-hexaene-2,10,17,25-tetrone

EC Number:

942-764-6

IUPAC Name:

2-({2-[(2-aminoethyl)amino]ethyl}carbamoyl)benzoic acid; 2-{[2-({2-[(2-carboxyphenyl)formamido]ethyl}amino)ethyl]carbamoyl}benzoic acid; 3,6,9,18,21,24-hexaazatricyclo[24.4.0.0¹¹,¹⁶]triaconta-1(30),11,13,15,26,28-hexaene-2,10,17,25-tetrone

Test material form:

not specified

Details on test material:

- Identification: HT 939

In vivo test system

Test animals

Species:

human

Strain:

other: Caucasian

Sex:

male/female

Details on test animals and environmental conditions:

50 Humans (25 males and 25 females) aged between 21-38 for males and 18-60 for females

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: methylcellulose

Induction 2

Concentration / amount:

0.03 ml of the test materials was applied.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: methylcellulose

Challenge 2

Concentration / amount:

0.03 ml of the test materials was applied.

No. of animals per dose:

25 humans males and 25 humans females

Details on study design:

See any other information on materails and methods incl. tables.

Positive control substance(s):

no

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Reading:

other: Challenge

Group:

test chemical

Dose level:

0.03 ml of HT 939

No. with + reactions:

0

Total no. in group:

50

Remarks on result:

other: Reading: other: Challenge. Group: test group. Dose level: 0.03 ml of HT 939. No with. + reactions: 0.0. Total no. in groups: 50.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There was no evidence of skin senstization noted with HT 939 under these conditions test.

Executive summary:

The study was performed to determine to possibility of HT 939 to induce skin irritation.

50 caucasian Humans (25 males and 25 females ) were used to performed the experiment.

The repeated insult technique was used in the patch test which called for a series of 9 induction patches of the test material to be placed on each of the subjects. The series was foliowed 12 days later by a single challenge patch of each test material to detect skin sensitization.

The series of 9 induction patches was applied according to the following schedule. A patch of each test material was applied on Monday, Wednesday and Thursday and allowed to contact the skin for 24 hours, after which time it was removed and the skin site graded for irritation. Thursday's patch was placed immediately after removal and grading of Wednesday's application.

After the ninth induction patch had been placed, a nonpathing period of 12 days elapsed before the challenge patch was applied to detect sensitization reactions. For this 24-hour patch, a new skin site was used. This site was invariably chosen adjacent to the induction site; i . e . , one where repeated applications had been made during the series of patches. Due to the delayed reactions noted during the induction phase, the challenge patch sites were observed up to 7 days following application.

HT 939 was tested at a concentration of 10% in 3% methyl cellulose for the induction phase of the study.

In conclusion, there was no evidence of skin senstization noted with HT 939 in Humans.