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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-09-12 to 1989-10-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
EC Number:
258-946-7
EC Name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
Cas Number:
54060-92-3
Molecular formula:
C20H24N3O.CH3O4S C21H27N3O5S
IUPAC Name:
2‐{[2‐(4‐methoxyphenyl)‐2‐methylhydrazin‐1‐ylidene]methyl}‐1,3,3‐trimethyl‐3H‐indol‐1‐ium methyl sulfate
Details on test material:
- Name of test material: Astrazon Goldgelb GLN trocken

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult rabbits were used
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: individually in stainless steel cages
- Diet: "Ssniff K 4" (Ssniff Spezialdiäten GmbH, Soest), approx 100-120 g per animal and day feeding once per day in the morning
- Water: tap water was available for ad libitum consultion (between 7 and 19 hrs from automatic watering apparatus)
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-09-12 to 1989-09-19

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL pulverized test substance = ca. 60 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize and McDonals and Shadduck

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
3.33
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: two animals showed a mean score of 4.0 and one animal showed a mean score of 2.0
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
1.2
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: two animals showed an mean score of 1.3 and one animal showed an mean score of 1.0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
2.43
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: two animals showed a mean score of 2.3 and one animal of 2.7
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: all animals showed a mean chemosis score of 4
Irritant / corrosive response data:
The mucous membranes became whitishly discolored after 24 hours in two animals. One day thereafter all rabbits showed this discoloration. 72 hours following exposure necrosis of the conjunctivae was observed in all animals. In one rabbit the nictitating membrane was blood-covered. Discharge became white-yellowishly discolored in two animals.
Since these findings had to be considered as irreversible animals were sacrificed after 72 hours.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute eye irritation/corrosion study according to OECD 405, the test substance causes severe eye-irritating effects.
Executive summary:

In a primary eye irritation study, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three female New Zealand White rabbits for 24 hours, and subsequently washed out with physiological saline. The animals were observed for a period of 72 hours. Irritation was scored by the method by Draize. In this study, the test item is corrosive to the eye based on necrosis of the conjunctivae and severe effects on the corneal opacity.