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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well described; no GLP Read across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point

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:
yes
Remarks:
Observation period of 8 days; no observation at 14, and 21 days in order to determine the status of the lesions, and their reversibility or irreversibility
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Malachite Green
IUPAC Name:
Malachite Green

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hagemann GmbH & C0
- Weight at study initiation: 2.4 kg
- Diet: Mummel Z ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 18°C
- Humidity: 40%
- Photoperiod: 12 Hrs cycle dark/light

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration 100 µL
Number of animals or in vitro replicates:
3 male rabbit
Details on study design:
SCORING SYSTEM:
OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 12
Max. score:
20
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 12.6
Max. score:
20
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 12.6
Max. score:
20
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: See comments
Irritant / corrosive response data:
cornea: pearl red. No visible details of iris. size of the pupil slightly different

Applicant's summary and conclusion

Interpretation of results:
other: CLP: Eye dam. 1
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance is classified as high irritant. No regression of tissue lesions before 8 day.
Executive summary:

Number of 3 Newzeland white rabbit as chosen to test Malachite Green for eye irritation/corrosion following OECD guideline 405.

The substance is classified as high irritant. No regression of tissue lesions before 8 day. Nevertheless no data available on reversibility or irreversibility of the substance, because no observation were conducted at 14, and 21 days in order to determine the status of the lesions.