Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-hydroxyethyl)ammonium 7-{4-[4-(2-cyanoamino-4-hydroxy-6-oxidopyrimidin-5-ylazo)benzamido]-2-ethoxy-phenylazo}naphthalene-1,3-disulfonate
EC Number:
421-440-3
EC Name:
Tris(2-hydroxyethyl)ammonium 7-{4-[4-(2-cyanoamino-4-hydroxy-6-oxidopyrimidin-5-ylazo)benzamido]-2-ethoxy-phenylazo}naphthalene-1,3-disulfonate
Cas Number:
778583-04-3
Molecular formula:
Hill formula: C47 H66 N12 O19 S2 CAS formula: C29 H21 N9 O10 S2 x 3 C6 H15 NO3
IUPAC Name:
tris(tris(2-hydroxyethyl)azanium) 2-(cyanoamino)-5-{2-[4-({4-[2-(6,8-disulfonaphthalen-2-yl)diazen-1-yl]-2-methoxyphenyl}carbamoyl)phenyl]diazen-1-yl}-6-hydroxypyrimidin-4-olate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D - 88397 Biberach / Riss, Germany
- Age at study initiation: 15-17 weeks
- Weight at study initiation: 2.8-3.1 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1996-08-14 To: 1996-08-22

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single treatment with the test item.
Observation period (in vivo):
Observation at 1, 24, 48, and 72h after instillation of the test item into the eye.
Number of animals or in vitro replicates:
Three animals (1 male, 2 females)
Details on study design:
SCORING SYSTEM: Standard Draize system
Corneal irritation: 0-4
Iris irritation: 0-2
Conjunctival redness: 0-3
Chemosis: 0-4

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean values 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean values 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean values 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks on result:
other: conjunctiae redness (score = 2) was observed only at hour 1, but was zero after 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean values 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks on result:
other: chemosis observed (max. score = 1) was observed only at hour 1, but was zero after 24 hours
Irritant / corrosive response data:
The substance showed a primary irritation score of 0.00, when applied to the conjunctival sac of the rabbit eye.
After one hour, moderate reddening of the conjunctivae and slight watery discharge were noted in all animals, and slight swelling was noted in two of three animals. All signs of irritation were reversible after 24 hours.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
- Light orange staining of the sclera was seen in all animals after one hour. Light orange staining of the conjunctivae was noted after one and 24 hours in two of three animals.
- The body weight of the animals was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria, the substance is classified as "not irritating" to the eye.
Executive summary:

The primary irritation potential of the substance was investigated according to Directive 92/69 EEC, B.5. "Acute Toxicity - Eye Irritation", July 31, 1992, U. S. Environmental Protection Agency, Code of Federal Regulations 40, Part 798, Health Effects Testing Guidelines, Subpart E, Specific organ/tissue toxicity, Paragraph 798.4500 "Primary eye irritation", revised as of July 1, 1993, and OECD Guidelines for Testing of Chemicals, Section 4, number 405 "Acute Eye Irritation / Corrosion", adopted February 24, 1987.

0.1 g of the test item was instilled undiluted into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures.

The primary irritation score was 0.00 (max. 13). After one hour, reddening of the conjunctivae and watery discharge were noted in all animals, and swelling was noted in two of three animals. All signs of irritation were reversible after 24 hours. Light orange staining of the sclera was seen in all animals after one hour. Light orange staining of the conjunctivae was noted after one and 24 hours in two of three animals.

No corrosion was observed at any of the measuring intervals.

Based upon the referred classification criteria, the substance is classified as "not irritating" to the eye.