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Diss Factsheets

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:
From 19 October, 1992 to 09 November, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
EC Number:
269-505-3
EC Name:
Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
Cas Number:
68259-02-9
Molecular formula:
C25H19ClN10O16S5.5Na
IUPAC Name:
pentasodium 4-amino-6-({5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfonatophenyl}diazenyl)-3-[(2,5-disulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Animal #1 and #2: Approx. 16 weeks; Animal #3: Approx. 13 weeks
- Weight at study initiation: 2499 to 3257 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (lKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d, ad libitum.
- Water (e.g. ad libitum): Tap-water diluted with decalcified water, ad libitum.
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: From October 19, 1992 to November 9, 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (weight with unit): 100 ± 1 mg/animal
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Up to 21 d (The eyes of each animal were examined for irritation for approx. 1, 24, 48 and 72 h and 7, 14 and 21 d after instillation of the test substance).
Number of animals or in vitro replicates:
Three male animals
Details on study design:
Prior to test substance instillation, the animals were physically examined to ensure normal ocular surface integrity.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Slight blue discolouration of the cornea noted during 24, 48 and 72 h observation period.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: The conjunctival redness was difficult to score at 24, 48 and 72 h observation period, due to blue discolouration by the test substance.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Chemosis grade 2 (at 48 h) and grade 1 (at 72 h) for nictitating membrane.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Slight blue discolouration of the cornea noted during 24, 48 and 72 h observation period.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: The conjunctival redness was difficult to score at 24 and 48 observation period, due to blue discolouration by the test substance. Redness grade 2 (at 24 and 48 h) and grade 3 (at 72 h) for nictitating membrane.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Chemosis grade 1 (at 48 h) for scleral conjunctivae.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Slight blue discolouration of the cornea noted during 24, 48 and 72 h observation period.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: The conjunctival redness was difficult to score at 24 h observation period, due to blue discolouration by the test substance. Redness grade 2 (at 24 h) and grade 3 (at 48 and 72 h) for nictitating membrane.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: chemosis grade 1 (at 48 h) for nictitating membrane.
Irritant / corrosive response data:
Blue staining of the cornea, iris and/or conjunctivae by the test substance was noted during the study, which made scoring difficult or impossible. Ocular corrosion was not observed in any of the animals.
Other effects:
There were no signs of body weight variability, toxicity or mortality in any animal during the study period.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test substance was irritating to the eye.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance (of 100 % purity) in New Zealand White rabbits according to OECD Guideline 405 and EU Method B.5 in compliance with GLP.

A single dose of 100 ± 1 mg test substance was applied into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48 and 72 h and 7, 14 and 21 d post-instillation.

Blue staining of the cornea, iris and/or conjunctivae by the test substance at 24, 48 and 72 h made scoring difficult. During the study, blue staining of the fur on the head and paws was noted. Further, conjunctival redness of > 2 in 2/3 eyes was observed which had resolved within 21 d after instillation. There were no signs of body weight variability, toxicity or mortality in any animal during the study period.

Under the test conditions, the test substance was considered to be irritating to the eyes.