5-nitroisophthalic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Assesment of a possible irritating potential to the eye and to the eye mucosa

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-nitroisophthalic acid

EC Number:

210-568-3

EC Name:

5-nitroisophthalic acid

Cas Number:

618-88-2

Molecular formula:

C8H5NO6

IUPAC Name:

5-nitroisophthalic acid

Test material form:

solid

Details on test material:

IUPAC name: 5-Nitrobenzene-1,3-dicarboxylic acid
Mol. formula: C8H5NO6
Molecular Weight: 211.128 gm/mol
Smiles: OC(=O)c1cc(cc(c1)[N+](=O)[O-])C(=O)O
InChI: InChI=1S/C8H5NO6/c10-7(11)4-1-5(8(12)13)3-6(2-4)9(14)15/h1-3H,(H,10,11)(H,12,13)

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation:
Male: 2.66 kg
Female: 2.45 kg
- Housing: Cage made of stainless steel with wire mesh walk floors. Floor area: 40cm x 51 cm
- Diet (e.g. ad libitum): KLIBA 341. 4 MM; FIRMA KLINGENTALMUEHLE AG CH-4303 KAISERAUGST. SWITZERLAND (ABOUT 130 G PER ANIMAL PER DAY)
- Water : About 250ml tap water per animal per cage
- Acclimation period: Atleast 8 days before the beginning of the study: Same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): Fully air conditioned
- Photoperiod (hrs dark / hrs light): 12h/12h (6.00-18.00 hours/18.00-6.00 hours)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml bulk volume ( About 43 mg of the comminuted test substance)

Duration of treatment / exposure:

1Hr; 24Hrs; 48Hrs; 72Hrs; 8D after application.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

1 male
2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

> 3 - < 3.7

Max. score:

3.2

Reversibility:

not specified

Remarks on result:

other: Severe eye irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Score:

>= 0 - <= 0.3

Max. score:

0.1

Reversibility:

not specified

Remarks on result:

other: Normal

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

>= 1.3 - <= 2

Max. score:

1.7

Reversibility:

not specified

Remarks on result:

other: Well defined

Any other information on results incl. tables

Table 1: Body weight data

Animal	1	2	3
Animal no.	0201	0186	0161
Body weight (kg)	2.50	2.40	2.66
Sex	Female	Female	Male

Table 2: Scores of eye irritation study

Readings	Animal	Cornea OP	Iris	Conjunctiva		Symptoms
				Red	SW
1 hour	1	2	0	2	2	Pupil contracted
	2	3	0	2	2	Pupil contracted
	3	2	0	2	2
24 hour	1	3	0	2	2	S3
	2	3	0	2	2	S/RE/S3
	3	3	0	2	2	S3/S
48 hour	1	3	0	2	1	S3/S
	2	3	0	2	2	S/RE/S3
	3	4	0	2	2	S3/S
72 hour	1	3	1	2	1	S3/S
	2	3	0	2	1	S/RE/S3
	3	4	0	2	2	S3/S
8 day	1	3	1	2	0	S/RE/S3/PC/S4
	2	4	0	2	1	S/RE/S3/LH/S4
	3	4	1	2	2	S3/S/MV/S4
Mean	1	3.0	0.3	2.0	1.3
	2	3.0	0.0	2.0	1.7
	3	3.7	0.0	2.0	2.0
Mean		3.2	0.1	2.0	1.7

 

Explanation of symptoms:

S3: Loss of corneal tissue

S4: Study disconnected after 8 day because of severe opacity

LH: Loss of hair at margins of eyelids

MV: Marginal vascularization of the cornea

PC: Pupil contraction

RE: Small retraction in the eyelids

S: Suppuration

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test substance was observed to be irritating to the Eye when eye irritation study was conducted on rabbits.

Executive summary:

Study, according to OECD guideline 405, was conducted on rabbit (strain Vienna White) to observe the eye irritation potential of test substance. 0.1 ml bulk volume (about 43 mg of comminuted test substance) was applied to the conjunctival sac of the right eyelid of the test animals. One male and two female animals were tested. Readings were taken at 1H, 24H, 48H, 72H, 8 Day after the application.Clinical symptoms were observed within one hour of the application and at the end of observations period (8 days), symptoms like loss of corneal tissue, loss of hair at the margins of eyelid, marginal vascularization of the cornea, small retractions in the eyelid were observed. Based on the symptoms, the following scores for ocular lesions were assigned: cornea score -3.2, iris score -0.1 and conjunctivae score 1.7. Accordingly the substance is classified as irritating to eyes. .