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Description of key information

No study on skin or eye irritation are available with the substance. Studies performed with category substance LABS according to OECD 404 and 405 guidelines showed that this substance is considered corrosive to skin and eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification document on the read across category approach is included in IUCLID 13.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
5.33
Max. score:
8
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean of 1, 24, 48, 72 hrs
Score:
5.25
Max. score:
6
Reversibility:
not reversible
Remarks on result:
other: highly irritating
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Data not available
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Data not available
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
No skin irritation/corrosion study with the target substance is available. Data generated with the category substance LABS is considered pivotal to this endpoint and this is the most conservative approach. LABS is classified as category 1C according to CLP regulation (corrosive to skin) and therefore the target substance will also be classified as category 1C. .
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification document on the read across category approach is included in IUCLID section 13.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hrs and 6 days
Score:
46.9
Reversibility:
not fully reversible within: 6 days
Remarks on result:
other: the test substance LABS was moderately irritating but because of intensity of necrosis formation, the study was stopped at day 6. The test substance is considered corrosive
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Data not available
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Data not available
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Data not available
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Data not available
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
There is no eye irritation study available with the target substance. Data generated with the category substance LABS is considered pivotal to this endpoint and is the conservative approach. LABS is considered to be classified as category 1 (serious eye damage 1) and thus also the target substance will be classified as category 1. .
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

No skin irritation study is available with the target substance. Data generated with the cateogry substance LABS was considered the pivotal dataset for this endpoint as this would be the most conservative approach.

A primary dermal irritation study with LABS was performed according to OECD guideline 404. The shaved backs of 3 male and 3 female rabbits were exposed for 4 hours to 0.5 ml of LABS and observed for up to 14 days. Significant and persistent reddening was observed. Swelling was perceptible throughout and appeared to become more noticeable with time. Based on erythema and edema scoring after 24, 48 and 72 hours observation, the test substance is considered corrosive to the skin of rabbits and should be classified as corrosive category 1C according to CLP regulation.

Eye irritation:

No eye irritation study is available with the target substance. Data generated with the category substances LABS and LABS Na were considered the pivotal datasets for this endpoint as this would be the most conservative approach.

An eye irritation study with LABS was performed in accordance with OECD guideline 405. LABS was applied in 6 rabbits to the right eye with lower lid removed, while the left eye remained untreated and served as the control. Application of LABS appeared to be moderately irritating but due to the intensity of the necrosis formation the study was stopped at day 6. This leads to classification of LABS as corrosive to eyes (eye damage category 1) according to CLP regulation.

An eye irritation with LABS Na was performed in accordance with OECD guideline 405. LABS Na (0.1 ml) was applied to eyes of 3 rabbits. Eyes were either not rinsed, rinsed after 4 seconds of exposure or rinsed after 30 seconds of exposure. Severe (irreversible) irritation was observed when eyes were not rinsed. Less severe and fully reversible irritation was observed when rinsed after 30 seconds of exposure. Mild and fully reversible irritation was observed in animals with eyes rinsed 4 seconds after exposure. According to the OECD guideline and based on these results, the test substance LABS Na is considered to be classified as corrosive to eyes (serious eye damage category 1).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The test substance should be classified as corrosive to skin (Skin corrosive 1C) and corrosive to eyes (Serious Eye damage 1) according to classification criteria of Regulation (EC) No 1272/2008.

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