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Diss Factsheets

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:
2002-08-19 to 2002-08-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was carried out based on the guideline described in : EC Commission Directive 92/69/EEC, B.5, "Acute Toxicity-Eye irritation", OECD No. 405 and US EPA, OPPTS 870.2400, Acute Eye irritation, EPA 712-C-98-195, August 1998. Study was conducted in compliance with OECD Principles of GLP.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5; OECD 405 (1987)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
481-170-7
EC Name:
-
Cas Number:
502453-61-4
Molecular formula:
Hill formula: C23H30BrN3O2 CAS formula: C23H30N3O2.Br
IUPAC Name:
dimethyl(3-{[4-(methylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}propyl)propylazanium bromide
Constituent 2
Reference substance name:
Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
IUPAC Name:
Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
Details on test material:
Nature of substance: solid substance
- Name of test material (as cited in study report): 3-((9,10-Dihydr-9, 10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N, N-dimethyl-N-propyl-1-Propanaminium-bromid [Bluequat-Bromid]
- Molecular formula (if other than submission substance): C23H30N3O2.Br
- Molecular weight (if other than submission substance): 460.42
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: See below
- Impurities (identity and concentrations): See below
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: See below
- Lot/batch No.: Not available
- Expiration date of the lot/batch: See below
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in dark
- Other: None

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: At least 6 weeks old
- Weight at study initiation: At least 1 kg
- Housing: Individually in labeled cages with perforated floors (Scanbur, Denmark, dimensions 56 X 44 X 37.5 cm)
- Diet (e.g. ad libitum): Standard Laboratory Diet (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx. 100 gm per day
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark


IN-LIFE DATES: From: 2002-08-19 To: 2002-08-22

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
33 MG
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 33mg (a volume of approximately 0.1 ml)
- Concentration (if solution): Undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
each animal was treated by instillation of 33 mg of the test substance (a volume of approximately 0.1 ml) in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24 hour observation, a solution of 2 % fluorescein in water (adjusted to pH 7) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Observation period (in vivo):
Approximately 1, 24, 48 and 72 hours after instillation of the test substance.

Number of animals or in vitro replicates:
3 male New Zealand White animals (SPF-quality)

Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: None


SCORING SYSTEM: Not available


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max. duration : 48 h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: 0verall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period : (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period : (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days

Other effects:
Blue staining of eyelids, nictitating membrane, sclera and
of fur of the head and paws was noted during the observa-
tion period. Remnants of the test substance were present

on the outside of the eyelids of all animals on day 2 and 3.
No systemic toxic effects were observed.

Any other information on results incl. tables

Average of 24/ 48/ 72 hours

Council Directive 67/548/EECClassification

Animal #

Cornea

Iris

Conjunctival redness

Conjunctival chemosis

Days to clear by individual animal

Not classified

420

0

0

0.3

0

Recovery by 48 hours

Not classified

457

0

0

0

0

No ocular effects were seen

Not classified

493

0

0

0.3

0

Recovery by 48 hours

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: other: Council Directive 67/548/EEC
Conclusions:
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 3-((9,10-Dihydr-9, 10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N, N-dimethyl-N-propyl-1-Propanaminium-bromid [Bluequat-Bromid] does not have to be classified.
Executive summary:

Instillation of approximately 33 mg of the test substance (a volume of approximately 0.1 ml) into one eye of each of three rabbits resulted in irritationof the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48 hours in two animals and within 24 hours in the other animal. At the 1 hour observation point, scoring of the lower eyelid was not possible due to blue staining by the test substance. No iridial irritation or corneal opacity was observed. There was no evidence of ocular corrosion. Based on the observations and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 3-((9,10-Dihydr-9, 10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N, N-dimethyl-N-propyl-1-Propanaminium-bromid [Bluequat-Bromid] does not have to be classified.