Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

EC Number:

276-521-4

EC Name:

Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Cas Number:

72245-24-0

Molecular formula:

not applicable

IUPAC Name:

Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: in single cages.
- Diet: standard laboratory diet ad libitum.
- Water: standard laboratory water were provided ad libitum.
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: 15 changes/hour
- Photoperiod: 12 hours cycle dark/light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg of the test material

Duration of treatment / exposure:

Single injection

Observation period (in vivo):

at 30 min, 24, 48 and 72 h

Number of animals or in vitro replicates:

Three male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
-Washing: not performed

-SCORING SYSTEM
Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1,#2, #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: unrinsed eye

Results 2

Irritation parameter:

iris score

Basis:

animal: #1,#2, #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: unrinsed eye

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1,#2, #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: unrinsed eye

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1,#2, #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: unrinsed eye

Applicant's summary and conclusion

Interpretation of results:

other: not irritating for rabbit eye

Conclusions:

The test substancwas found to be not irritating for the rabbit eye.

Executive summary:

The eye irritation was evaluated in an in vivo test performed following a method similar to the OECD Guideline 405 method. Three rabbits were treated with 100 mg of test material directly injected into the conjunctival sac; the left eye served as control. The evaluation of eye reactions were performed without washing the treated eyes. The observation period had to be 21 days but the end was anticipated at 72 hours since no signs of eye irritation were observed. The scores for corneal opacity, iritis, conjunctival redness and oedema (mean values at 24/48/72 h) were 0 in all animals.