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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Skin irritation/corrosion:
- test substance (500mg, 4 hours, semi-occlusive) was slightly to moderately irritant to rabbits. [OECD TG 404, GLP]
Eye irritation:
- test substance was severly irritating to the eyes of rabbits. [OECD TG 405, GLP]

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: None. Substance was applied directly
Controls:
not specified
Amount / concentration applied:
Amount applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
11 d
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 11d
Remarks on result:
other: Max. duration: 10d; Max. value at end of observation period: 0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 11d
Remarks on result:
other: Max. duration: 10d; Max. value at end of observation period: 0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 11d
Remarks on result:
other: Max. duration: 10d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 11d
Remarks on result:
other: Max. duration: 10d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 11d
Remarks on result:
other: Max. duration: 10d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 11d
Remarks on result:
other: Max. duration: 10d; Max. value at end of observation period: 0
Other effects:
No further toxicological effects
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Erythema and oedema were observed in all animals, so the substance is slightly to moderately irritating to the skin of rabbits.
Executive summary:

The test substance was tested to be slightly to moderately irritating to the skin of rabbits ( 3 animals) in a GLP study according to OECD Guideline No. 404, but the effects are not sufficient to be classified as skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Amount / concentration applied:
Amount applied: 100 mg
Duration of treatment / exposure:
24 h
Number of animals or in vitro replicates:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: 24 h
Score:
2
Max. score:
2
Reversibility:
other: test terminated before reversibility could be determined.
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
other: test terminated before reversibility could be determined.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
other: test terminated before reversibility could be determined.
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
other: test terminated before reversibility could be determined.
Other effects:
No further toxicological observations.

Due to the severeness of the damages the test was cancelled after 24 h for reasons of animal protection.

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The substance is severely irritating to the eyes of rabbits.
Executive summary:

The test substance was tested to be severly irritating to the eyes of rabbits ( 1 animals) in a GLP study according to OECD Guideline No. 405. Due to the severeness of the damages the test was cancelled after 24 h for reasons of animal protection.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

The test substance was tested to be slightly to moderately irritating to the skin of rabbits ( 3 animals) in a GLP study according to OECD Guideline No. 404, but the effects are not sufficient to be classified as skin irritant.

Eye irritation:

The test substance was tested to be severly irritating to the eyes of rabbits ( 1 animals) in a GLP study according to OECD Guideline No. 405 (due to the severeness of the damages the test was cancelled after 24 h for reasons of animal protection) and is therfore to be classified.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline study

Justification for selection of eye irritation endpoint:
GLP and guideline study

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation/corrosion:

The test material does not meet the criteria for classification and will not require labelling as irritating / corrosive to the skin in accordance with European Regulation (EC) No. 1272/2008.

Eye irritation:

The test material has the potential to seriously damage the eyes and is therefore classified in Category 1 (irreversible effects on the eye; H318: Causes serious eye damage) in accordance with European Regulation (EC) No. 1272/2008.