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

Eye irritation

Administrative data

Endpoint:

eye 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:

secondary source

Title:

eye 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:

Eye 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 the irritancy potential caused by the chemical.

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 / tissue source

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or tissues and environmental conditions:

no data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Amount :100%
concentration applied: 100mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Immediate after treatment, and then at intervals of 10 minutes, 1 hour, and at 24, 48, 72 and 168 hours.

Number of animals or in vitro replicates:

6 (male/female)

Details on study design:

TEST SITE
- Area of exposure: one eye of six albino rabbits
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24hour

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Immediate findings

Reversibility:

not specified

Remarks on result:

other: slight discomfort.

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: At 10 minutes and 1 hour

Reversibility:

not specified

Remarks on result:

other: Slight erythema and discharge

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

other: slight erythema and discharge

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 and 72 hours

Score:

0

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

other: The average Draize score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The conjunctival erythema observed at 24 hours in all the animals. There was no evidence of eye irritation at 48 hours in any of the animals.

Any other information on results incl. tables

Immediate findings: slight discomfort.

At 10 minutes: Slight erythema and discharge

At 1 hour: slight erythema and discharge

At 24 hours: slight erythema and discharge

At 48 hours: all animals scored "0"

At 72 hours: all animals scored "0"

The average Draize score for 24, 48 and 72 hours was 1.3.

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 eye of New Zealand White rabbits.

Executive summary:

An eye 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 the irritancy potential caused by the chemical.

 

Duringthetest100.0 mg of the undiluted test substance as a finely ground powder was applied to one eye of six albino rabbits. The other eye was not treated and served as a control. The cornea, iris and conjuntivae were examined immediately after treatment, and then at intervals of 10 minutes, 1 hour, and at 24, 48, 72 and 168 hours. The Draize Method was used for scoring eye irritation.

 

 

The average Draize score for 24, 48 and 72 hours was calculated for each animal and then averaged over the six animals. The average Draize score was 1.3 on scale from 0-110.

 

Since there was no evidence of eye irritation at 48 hours in any of the animals, the chemical 1,4-benzenediamine, N-(1-methylethyl)-N'-phenyl (CAS no: 101-72-4)was considered to benot irritatingto the eye ofNew Zealand Whiterabbits.