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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 substance is Category 1 corrosive on the basis of destruction of skin tissue (visible necrosis through the epidermis and into the dermis) , as cobserved in a study on rabbits.
Three subcategories are provided within the corrosive category: Subcategory 1A – where responses are noted following up to 3 minutes exposure and up to 1 
hour observation; subcategory 1B  –  where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days; and subcategory 1C – where 
responses occur after exposures between 1 hour and 4 hours and observations up to 14 days. 
The test provided did not note reaction times of under 4 hours, the severe and irrevesible skin damage produced in all tested animals indicate that the substance is likely to be severely corrosive to the skin. 
(ECHA Guidance on the Application of the CLP  Criteria Nov 2013)
Furthermore, read-across from structurally similar substances shows good correlation wth regard to the corrosive effects.
The corrosive potential of the substance is also confirmed in repeat-oral dose animal toxicity studies, where noticeable and severe lesions of the forestomach and GI tract, along with clinical signs of distressed animals, are supportive of the corrosive classification.

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: The study preceeds current OECD guidelines, however is equivalent to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). No GLP, however the study is sufficiently reported and the results unambiguous.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Type of coverage:
open
Preparation of test site:
other: Intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml per application
Duration of treatment / exposure:
4-72 hours
Number of animals:
3 dose groups of 6 aminals each for intact skin
3 dose groups of 6 aminals each for abraded skin
32 animal in total
No controls
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: after 4hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to skin of Rabbits.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: after 4 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severly damaging to skin of rabbits
Irritation parameter:
edema score
Basis:
mean
Score:
>= 0 - < 1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to skin of rabbits
Irritant / corrosive response data:
Severely damaging to skin of rabbits. No recovery noted in any animal after 30-day recovery period.
Other effects:
For intact and abraded skin, at all does levels there was vocalisation and ataxia, with abraded skin animals showing more makred effects.
Increasing doses showed signs of decresed activity, prostration, lethargy ataxia, dyspnea and death.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The subsatnce is corrosive to the skin of rabbits, with no recovery afte a 30-day recovery period. The substance should be considerd corrosive to the skin and eyes, nasal and respiratory tracts.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study preceeds current OECD guidelines, however is equivalent to OECD Guideline 405 (Acute Eye Irritation / Corrosion). No GLP, however the study is sufficiently reported and the results unambiguous.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
5 minutes exposure with 48-hour observation period
24-hours exposure with 72-hour observation period
Number of animals or in vitro replicates:
2 groups, 8 per group
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 5 minute sexposure
Score:
>= 1 - < 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to eyes of rabbits.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-hour exposure
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to eyes of rabbits.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 5 minute exposure
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to eyes of rabbits.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour exposure
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to eyes of rabbits.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 5 minute exposure
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to eyes of rabbits.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hour exposure
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Severely damaging to eyes of rabbits.
Irritant / corrosive response data:
The substance is severely damaging to eyes of rabbits, with no recovery after 30-day observation period.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is severely damaging to eyes of rabbits, with no recovery after 30-day observation period. The substance is severely irritating and corrosive to the skin and eyes.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
In a skin irritation study in Rabbits using intact and abraded skin, the substance was found to be severely damaging, with no recovery noted in any animal after 30-day recovery period.
The substance is corrosive.

Justification for selection of eye irritation endpoint:
In an ocular irritation study in rabbits, the substance was severely damaging to the eyes, with no recovery after 30-day observation period.
The substance is severely irritating and corrosive to the skin and eyes.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: highly irritating

Justification for classification or non-classification

In a skin irritation study in Rabbits using intact and abraided skin, the substance was found to be severely damaging, with no recovery noted in any animal after 30-day recovery period. In an ocular irritation study in rabbits, the substance was severely damaging to the eyes, with no recovery after 30-day observation period. The substance has been demonstrated to be corrosive to the skin and eyes of rabbits. Corrosion damage was not reversible after 30 days.

Based on the result of in vivoskin irritation study, the substance needs to be classified as C, R34 according to the DSD and as Category 1B, H314 under the CLP classification criteria.The substance needs to be classified with Xi, R41 and Eye Damage 1, H318 according to classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008, respectively