Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 December 2007 - 30 December 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

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 OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
484-490-5
EC Name:
-
Molecular formula:
Hill formula:C21 H12 N2 O6 S Sr 5/2(H2O) CAS formula: C21 H14 N2 O6 S . Sr
IUPAC Name:
484-490-5
Test material form:
solid: granular
Details on test material:
Red Powder.
Batch-070711
Purity>=96.4 %
Storage-Room temperature in the dark.
Stable under storage conditions.
Epiry date-11 July 2011

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands.
- Age at study initiation: 6 weeks old.
- Weight at study initiation: 1 kg
- Housing: Housed individually in labelled cages with perforated floors.
- Diet (e.g. ad libitum): Pelleted diet for rabbits approx 100 grams per day. Hay (Tecnilab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-21.7 °C
- Humidity (%): 42 %-60 %
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours artificial light.

IN-LIFE DATES: From: 11 December 2007 To: 30 December 2007

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30.3 - 30.4 mg (a volume of approximately 0.1 mL)

Duration of treatment / exposure:
72 Hours.
Observation period (in vivo):
1, 24, 48, and 72 hours.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure:

SCORING SYSTEM: Not specified

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein- Not specified.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48hours
Irritant / corrosive response data:
There was no evidence of occular corrosion.

Any other information on results incl. tables

No symptoms of systemic toxicity were observed in the animals during the test period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results, R507-2 does not have to be classified and has no obligatory labelling requirement for Eye irritation according to the GHS of Classification and labelling of Chemicals of the United nations (2004) and EC criteria for classification and labelling (1272/2008).
Executive summary:

Single samples of approximately 30mg of R507 -2 ( a volume of approx 0.1mL) were instilled into each eye of each of the three rabbits. Observations were made at 1, 24, 48, and 72 hours after instillation.

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 48 hours.

Remnants of the test substance were present in the eye during Day 1 and on the outside of the eyelids during the observation period. Red staining of the fur on the head and the paws, caused by the test substance, was noted throughout the observation period.

Based on these results, R507-2 does not have to be classified and has no obligatory labelling requirement for Eye irritation according to the GHS of Classification and labelling of Chemicals of the United nations (2004) and EC criteria for classification and labelling (1272/2008).