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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance is corrosive to skin and mucous membranes (severely eye damaging).

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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.
Principles of method if other than guideline:
1 male and 1 female rabbit were tested for local skin tolerance by application of a gauze patch filled with the test substance on the hairless skin of the ear
GLP compliance:
no
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 8 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.
Principles of method if other than guideline:
1 male and 1 female rabbit were tested for eye irritation/corrosion by application of test substance into the conjuctival sac.
GLP compliance:
no
Remarks:
prior to GLP
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: over all time points up to 6 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean over all time points up to 6 days
Score:
4
Max. score:
4
Reversibility:
not reversible
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

The in vivo skin irritating potential of the test substance was investigated in non-GLP study (on a similar basis to OECD404). One male and one female rabbit were tested for local skin tolerance by application of a gauze patch filled with the unchanged test substance on the hairless skin of the ear (semi-occlusive coverage). The two treated animals (1 and 8 h exposed rabbits respectively) showed a very strong erythema with partial skin corrosion during the entire follow-up. Up to two days after treatment, the skin was also slightly swollen. Observed effects were not reversible within 7 days. The test substance is classified as corrosive (ECHA dissemination dossier, Joint submission, 2012).

 

Eye irritation/corrosion:

The in vivo eye irritating potential of the test substance was investigated in a non-GLP study (on a similar basis to OECD405).One male and one female rabbit were tested for eye irritation/corrosion by application of 50 mg unchanged test substance into the conjuctival sac without washing. The untreated eye served as control. The conjunctivae were up to 6 days after treatment severely and thereafter moderately reddened and swollen. The cornea was completely burned. Thus, the test substance is corrosive to the eyes (ECHA dissemination dossier, Joint submission, 2012).


Justification for selection of skin irritation / corrosion endpoint:
Estimated Klimisch rating: 2

Justification for selection of eye irritation endpoint:
Estimated Klimisch rating: 2

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results for skin irritation (corrosive) and for eye irritation, the test substance is classified for skin irritation/corrosion as follows:

 

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 (CLP). As a result the substance is considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014, as follows:

Cat. 1B, H314, causes severe skin burns and eye damage; Cat. 1, H318, causes serious eye damage.

 

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 considered to be classified under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG, as follows:

The symbol “C”, the indication of danger “Corrosive”, and R34 (causes burns), R41 (risk of serious damage to eyes).