Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
EC Number:
226-109-5
EC Name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
Cas Number:
5281-04-9
Molecular formula:
C18H14N2O6S.Ca
IUPAC Name:
calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10868 / Irgalite Rubine 6BL
- Analytical purity: 89% Pigment Red 57:1
- Substance type: red pigment
- Physical state: solid
- Purity test date: not available
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
Californian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.44 kg (males) and 2.31 kg (males)
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) :ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours daily from 0800 - 1800 hours


IN-LIFE DATES: From: July 20, 1987 To: July 24, 1987

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.06 g per eye, corresponding to 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
2 males and 2 females
Details on study design:
The rabbits were examined, using a direct ophthalmoscope, at 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met