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 irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 followed

Principles of method if other than guideline:

The study was performed to determine the possibility of the test item to induce skin irritation.
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 irritant or not to Human skin.

GLP compliance:

no

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.

Test animals

Species:

other: Human

Strain:

other: Caucasian

Details on test animals or test system and environmental conditions:

- Age at study initiation: 21-38 for male (25) and 18-60 for female (25)
- Race: Caucasian

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: 3% methylcellulose

Controls:

no

Amount / concentration applied:

0.03 mlof HT 939 was applied.

Duration of treatment / exposure:

A patch with HT 939 was applied on Monday, Wednesday and Thursday and allowed to contact the skin for 24 hours

Observation period:

72 hours

Number of animals:

50 caucasian Human (25 males and 25 females)

Details on study design:

Fifty human subjects were employed in the investigation.
A patch of HT 939 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.


Skin application the test material was made using Readi-Band* "hypoallergenic nonirritating" clear plastic patches 1-1/2" x 1-1/2" square
with nonwoven Webril centers. Approximately 0.03 ml of the test materials was applied on the Webril center of the patch just prior to application.

SCORING SYSTEM:
Scoring Criteria for Skin Irritation Reactions
Erythema and Eschar Formation
- No reaction: 0
- Very slight erythema (barely perceptible): 1
- Mild, well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Total possible erythema score 4

Edema Formation
- No reaction: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edge of area well -defined by definite raising: 2
- Moderate edema (area raised approximately 1 mm 3
- Severe edema (area raised more than 1 mm and extending beyond area of exposure): 4

Total possible edema score 4
Total possible irritation score 8

Results and discussion

In vivo

Results

Remarks on result:

other: Patch test performed on 50 Humans (25 males and 25 females). Based on the incidence and severity of the reactions, the test material would not be considered a primary skin irritant under the exaggerated test conditions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the incidence and severity of the reactions, the test material would not be considered a primary skin irritant under the exaggerated test
conditions .

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 test material was evaluated at a concentration of 10% in 3% methyl cellulose.

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.

Based on the incidence and severity of the reactions, the test material would not be considered a primary skin irritant under the exaggerated test conditions.