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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 and eye irritation was tested in rabbits prior to the introduction of OECD testing and GLP guidelines. The eye irritation design is identical to that of the OECD guideline 405 whereas the skin irritation study design is more stringent, but has a shorter observation time point. Slight reversible findings below the threshold for classification and labelling were observed.

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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
less reporting details on test animals and test item. More stringent exposure regime
Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.41, 1973 (Draize test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
Mean body weight: 3.0 kg
The animals were offered a standardized animal laboratory diet.
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: paraffin oil
Controls:
other: untreated skin
Amount / concentration applied:
0.5 g of a 50% aqueous test substance preparation in paraffin oil
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
Application area: 2.5 x 2.5 cm
Application site: back
The test substance was not washed off.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.6
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.75
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.6
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.15
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: abraded skin
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
less reporting details on test material and housing conditions
Principles of method if other than guideline:
according to Fed. Reg. 187, § 1500.42, 1973 (Draize test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Mean body weight: 3.0 kg
The animals were offered a standardized animal laboratory diet.
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes
Amount / concentration applied:
32 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test substance was not washed out.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.4
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

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. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.