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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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-09-12 to 1989-10-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

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:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
EC Number:
268-750-3
EC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
Cas Number:
68134-38-3
Molecular formula:
C20H24ClN3
IUPAC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Hagemann Gmbh&Co- Weight : 2.3 kg (medium)- Housing: individually cages- Diet: "Mummel Z" (Ssniff Spezialdiäten GmbH, Soest)- Water: tap water ad libitum consultion- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 216-18- Humidity (%): ca. 40 - Photoperiod (hrs dark / hrs light): 12/12

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
Duration of treatment / exposure:
1 second eye lids gently close
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE: the treated eyes were not rinsedSCORING SYSTEM: according to Draize and McDonals and ShadduckTOOL USED TO ASSESS SCORE: fluorescein in ophtalmological solution (1 drop)

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:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: all animals showed effetcs
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: all animals showed effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: all animals showe effects
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:
All animals showed strong effect on cornea, iris and conjunctivae.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
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 male New Zealand White rabbits. The animals were observed for a period of 8 days.
In this study, the test item is corrosive to the eye based on effects on conjunctivae, cornea and iris.