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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: irritating; rabbit, non-guidline (BASF test), non-GLP, K2


Eye irritation: irritating; rabbit, non-guidline (BASF test), non-GLP, K2

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
Study period:
1969/1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: BASF test
GLP compliance:
no
Species:
rabbit
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.72 and 2.25 kg
Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: back and ear
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
3.2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 20h treatment
Irritation parameter:
edema score
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 20 h treatment
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of two animals
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 15 minute treatment
Irritant / corrosive response data:
Necroses were observed after 20h treatment
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the findings of this study the test substance shows a clear skin irritation potential in rabbits after exposure to the test substance for 15 minutes or 20 hours and thus has to be classified as skin irritating (category 2) according to EU criteria and according to the OECD Globally Harmonized System.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969/1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: BASF test
GLP compliance:
no
Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca 2 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: 50 µl NaCl was applied into the left eye and served as control
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this test, the test substance is reversibly irritating to the eye und thus, is classified as mildly irritating to eyes (Category 2B).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion


In a skin irritation/corrosion BASF test (K2, non-GLP; BASF, 1970) two rabbits were exposed to the test substance for 15 min and 20 h, and observed for 8 d post dosing. The test substance showed a clear skin irritation potential after exposure to the test substance for 15 minutes or 20 hours.

Eye irritation


For the assessment of a possible eye-irritating potential, a BASF test (K2, non-GLP; BASF, 1970) was conducted by single instillation of 50 µL test substance in two rabbits with a subsequent 8-day observation period. Under the described conditions, the test substance appeared to be reversibly irritating to the eye.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. In the eye and skin irritation study, the test item caused clear eye and skin irritation. As a result, the substance is considered to be classified as eye irritating (Cat. 2) and skin irritating (Cat. 2) under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.