Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 11, 1990 - January 18, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline 405 study, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
EC Number:
408-210-8
EC Name:
Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
Cas Number:
124605-82-9
Molecular formula:
C33 H26 N8 O14 S4 .x Li .x Na
IUPAC Name:
dilithium(1+) disodium 5-amino-3-{2-[4-(2-{4-[2-(8-amino-1-hydroxy-3,6-disulfonaphthalen-2-yl)diazen-1-yl]-2-methylphenyl}diazen-1-yl)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonate
Details on test material:
- Physical state: powder
- Stability under test conditions: stable for at least 2 hours

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., 4414 Fuellinsdorf
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.5 kg, females: 3.0 - 3.2 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, Batch 50/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3 °C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
single installation without rinsing
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormalities observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: No abnormalities observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h -72 h
Score:
0
Max. score:
3
Reversibility:
other: No abnormalities observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h -72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Under the conditions of this experiment, the test substance was found to cause a cornea, iris and conjunctivae score of 0.00 and a chemosis score of 0.33 when applied to the conjunctival sac of the rabbit eye (24 - 72 h observation period). No corrosion was observed at any of the measuring intervals.
Other effects:
Blue staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed, by all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance caused only minimal chemosis reactions below the level of regulatory significance and is therefore classified as not irritating to the rabbit eye.
Executive summary:

In a GLP-compliant eye irritation study performed according to OECD guideline 405, three New Zealand White rabbits were treated with 0.1 g of the test article. The test article was placed into the conjunctival sac of the left eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The right eye remained untreated and served as a control. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The corrosive properties of the test article and the staining of the treated eye were described and recorded. Animals were checked daily for viability. The observation was terminated 72 hours administration of the test article. Under the conditions of this experiment, the test substance was found to cause a cornea, iris and conjunctivae score of 0.00 and a chemosis score of 0.33 when applied to the conjunctival sac of the rabbit eye (24 - 72 h observation period). The chemosis reaction was reversible within 48 hours. No corrosion was observed at any of the measuring intervals. Blue staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed, in all animals. Due to the results described above, the test article is considered to be not irritating to the rabbit eye.