N-[3-(diethylamino)phenyl]acetamide

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 Type:

review article or handbook

Title:

IUCLID Dataset

Author:

OECD

Year:

2004

Bibliographic source:

IUCLID Dataset - OECD -30-JUL-2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

An ocular irritation study of Trimellitic anhydride (CAS no: 552-30-7) was conducted on one New Zealand albino rabbits in order to examine the degree of eye irritation caused by the chemical .

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid

Cas Number:

552-30-7

Molecular formula:

C9H4O5

IUPAC Name:

1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Trimellitic anhydride (TMA)
- Molecular formula: C9H4O5
- Molecular weight: 192.1256 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc2c(cc1C(=O)O)C(=O)OC2=O
-InChI: 1S/C9H4O5/c10-7(11)4-1-2-5-6(3-4)9(13)14-8(5)12/h1-3H,(H,10,11)

Specific details on test material used for the study:

- Name of test material (as cited in study report): Trimellitic anhydride (TMA)
- Molecular formula: C9H4O5
- Molecular weight: 192.1256 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc2c(cc1C(=O)O)C(=O)OC2=O
-InChI: 1S/C9H4O5/c10-7(11)4-1-2-5-6(3-4)9(13)14-8(5)12/h1-3H,(H,10,11)
- Purity :98%
-Impurities:2%

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:

other: the other eye serving as the untreated control.

Amount / concentration applied:

Amount:1 00mg (0.1 g)
concentration applied: 100%

Duration of treatment / exposure:

14 days

Observation period (in vivo):

1, 2, 3, 4, 7, and 14 days following test article administration

Number of animals or in vitro replicates:

1 (male/female)

Details on study design:

- Area of exposure: one of the eye


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Score:

110

Max. score:

110

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

A reaction was considered positive if at any observation period, the test article produced ulceration or opacity of the cornea (cornea score > than 0), inflammation or slight circumcorneal injection of blood vessels of the iris (iris score > 0), any obvious conjunctival swelling with partial eversion of the lids (chemosis score 2 or greater), or conjunctival erythema of diffuse crimson red (erythema score 2 or greater) with individual vessels not easily discernable.

Other effects:

Signs of ocular irritation were maximum (i.e. Draize score 110/110) at the 24 hour examination and the study was terminated immediately thereafter with no dosing of any additional animals. The maximum eye irritation score of 110/110 was obtained 1 day after administration of test article.

Any other information on results incl. tables

DERMALIRRITATION SCORES
Skin reactions	Mean scores (time)
	30-60mins	24 hours	48 hours	2 hours	Day 7	Day 14
Edema score	1.8	1.0	0.3	0.3	0.0	0.0
Erythema and eschar formationscore	2.5	1.2	1.0	0.8	0.7	0.0
Irritation score	4.3	2.2	1.3	1.1	0.7	0.0
Irritation score= mean Edema score + mean Erythema score
primary dermal irritation score (PDIS) =1.7

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The maximum eye irritation score of 110/110 was obtained 1 day after administration of Trimellitic anhydride. Thus chemical Trimellitic anhydride (CAS no: 552-30-7) was considered to be severely irritating irritating irritant to the eye of New Zealand albino rabbit.

Executive summary:

An ocular irritation study of Trimellitic anhydride (CAS no: 552-30-7) was conducted on one New Zealand albino rabbits in order to examine the degree of eye irritation caused by the chemical.

 

It was anticipated that TMA might be a severe eye irritant. Therefore, out of concern for animal pain and discomfort, only one rabbit was used initially as a test subject.

 

TMA was administered undiluted at a dose of 100mg (0.1mg) into one eye with the other eye serving as the untreated control. The treated eye was scored for irritation at 1, 2, 3, 4, 7, and 14 days following test article administration. Irritation was scored using the Draize method. A reaction was considered positive if at any observation period, the test article produced ulceration or opacity of the cornea (cornea score > than 0), inflammation or slight circumcorneal injection of blood vessels of the iris (iris score > 0), any obvious conjunctival swelling with partial eversion of the lids (chemosis score 2 or greater), or conjunctival erythema of diffuse crimson red (erythema score 2 or g greater) with individual vessels not easily discernable.

 

Signs of ocular irritation were maximum (i.e. Draize score 110/110) at the 24 hour examination and the study was terminated immediately thereafter with no dosing of any additional animals.

 

The maximum eye irritation score of 110/110 was obtained 1 day after administration of Trimellitic anhydride.Thus chemicalTrimellitic anhydride (CAS no: 552-30-7) was considered to be severely irritating to theeyeofNew Zealand albinorabbit.