2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment report

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

N-ISOPROPYL-N’-PHENYL-P-PHENYLENEDIAMINE; CAS N°:101-72-4

Author:

OECD SIDS

Year:

2000

Bibliographic source:

OECD SIDS- SIDS Initial Assessment Report for SIAM 10 Tokyo, 15-17 March 2000

Reference 2

Reference Type:

review article or handbook

Title:

skin irritation for CAS 101-72-4 (1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl)

Author:

U.S. Environmental Protection Agency

Year:

2017

Bibliographic source:

High Production Volume (HPV) Challenge Program; 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin irritation study of 1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl (CAS no: 101-72-4) was conducted on six New Zealand White rabbits in order to determine he irritancy potential caused by the chemical under occlusive condition.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl

Cas Number:

101-72-4

Molecular formula:

C15H18N2

IUPAC Name:

1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl

Test material form:

solid

Details on test material:

- Name of test material: N-isopropyl-N'-phenyl-p-phenylenediamine
- Molecular formula: C15H18N2
- Molecular weight: 226.321 g/mol
- Smiles notation: c1(Nc2ccccc2)ccc(NC(C)C)cc1
- InChl: 1S/C15H18N2/c1-12(2)16-14-8-10-15(11-9-14)17-13-6-4-3-5-7-13/h3-12,16-17H,1-2H3
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material: N-isopropyl-N'-phenyl-p-phenylenediamine
- Molecular formula: C15H18N2
- Molecular weight: 226.321 g/mol
- Smiles notation: c1(Nc2ccccc2)ccc(NC(C)C)cc1
- InChl: 1S/C15H18N2/c1-12(2)16-14-8-10-15(11-9-14)17-13-6-4-3-5-7-13/h3-12,16-17H,1-2H3
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or test system and environmental conditions:

no data available

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

24 hours

Observation period:

24, 48, 72 and 168 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal areas
- % coverage:
- Type of wrap if used: 1" square gauze patches were used and held in contact with the skin by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24hour

SCORING SYSTEM: Draize, J.H., Woodard, G., and Calvery, H.O., 1944

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No known signs of skin irritation were observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

The test material 1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl (CAS no: 101-72-4) was considered to be Not irritating to the skin of New Zealand White rabbits.

Executive summary:

Skin irritation study of 1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl (CAS no: 101-72-4) was conducted on six New Zealand White rabbits in order to determine he irritancy potential caused by the chemical under occlusive condition.

 

During the test 0.5 ml of the test substance as a finely ground powder moistened with water was applied to the shaved dorsal areas of six albino rabbits. The test material was applied to the skin under 1" square gauze patches and held in contact with the skin by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape. The occlusive wrap and gauze patches were removed after 24 hours. Dermal irritation was scored by the Draize Method, and results were recorded 24, 48, 72 and 168 hours after topical application.

 

The Primary Irritation Index was calculated by averaging the mean scores at 24 and 72 hours. All animals scored zero (0) at every observation time. Hence the test chemical1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl (CAS no: 101-72-4)was considered to beNot irritatingto the skin ofNew Zealand White rabbits.