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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD test guideline 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

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

Test material

Constituent 1
Reference substance name:
2-methylundecan-2-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate
EC Number:
700-958-6
Molecular formula:
UVCB Substance
IUPAC Name:
2-methylundecan-2-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate
Details on test material:
- Description: blue powder
- Expiration date of the batch: 01-Apr-1997
-Stability under storage conditions: stable

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: approximately 12 weeks old
- Weight at study initiation: 2474-2688 g
- Housing: individually, in labelled cages with perforated floors
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter of 4 mm; Hope Farms, Woerden, The Netherlands), approximately 100 g/day
- Water: tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 55 ± 1 mg/rabbit
Duration of treatment / exposure:
(1 day)
Immediately after the 24 hour observation, the treated eye was rinsed to remove possible remnants of the test item. However, the test item could only partly be removed.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: both eyes of all 3 animals were rinsed with approximately 50 mL tepid tap water per eye, using a velocity of flow which did not affect the eyes, to remove residual test item.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours (mean)
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: pannus persisted until termination
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: corneal opacity (grade 1) and pannus persisted until termination
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours (mean)
Score:
0
Max. score:
2
Reversibility:
other: not applicable, no effect
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours (mean)
Score:
0
Max. score:
2
Reversibility:
other: not applicable, no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours (mean)
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48, 72 hours (mean)
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24, 48, 72 hours (mean)
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24, 48, 72 hours (mean)
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours (mean)
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Corneal opacity became apparent and epithelial damage was noted, confirming corneal injury, 24 hours after instillation in all animals. Pannus, neovascularisation of the cornea, was noted after 7 days in all animals. The corneal injury (opacity, epithelial damage and pannus) had resolved within 14 days after instillation in one animal (#1). Although, opacity and epithelial damage had resolved within 7 days, pannus was still observed at termination in another animal (#2). The corneal injury had not resolved within the observation period in the remaining animal (#3). Corneal opacity grade 1 and pannus persisted in this animal until termination. The iridic irritation noted in all animals on the day of treatment had resolved within 24 hours after instillation. However, iridic irritation was again observed at the 72 hour observation in one animal (#3), which had resolved by the following observation. Conjunctival redness was present in all animals 24 hours after the instillation. Swelling (chemosis) of the conjunctivae was also seen in all animals on the day of treatment. The irritation of the conjunctivae had not completely resolved within the observation period in any of the animals. Slight conjunctival redness was observed at termination in all animals.
Other effects:
Blue staining of fur on the head and the paws of the animals was noted at all observations.
No toxic symptoms were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU