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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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.

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

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

Route:

epicutaneous, occlusive

Vehicle:

other: methylcellulose

Concentration / amount:

0.03 ml of the test materials was applied.

Route:

epicutaneous, occlusive

Vehicle:

other: methylcellulose

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

Positive control results:

Not applicable

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a human repeated insult patch the substance was determined to be non sensitiser.

Migrated from Short description of key information:
The skin sensitisation potential was determined in a human repeated insult patch test.

Justification for selection of skin sensitisation endpoint:
Only existing study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

- skin sensitisation:

Based on the above stated assessment of the skin sensitisation potential, the substance does not needs to be classified as Skin sensitiser according to CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.

- respiratory sensitisation:

As no data on respiratory sensitization is available for the substance a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.