Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating
Eye irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

The skin irritation dataset contains two studies performed using the substance to be registered and a further seven studies performed on read across substances.

In the key study, Younger (1966), the irritation potential of the undiluted test material was determined using 3 rabbits (2 male and 1 female). No guideline was followed. The clipped intact skin of each rabbit was exposed to the test material under an occlusive dressing for 24 hours. Animals were observed for signs of irritation for 7 days and scored in accordance with the Draize scale (1944). Under the conditions of the test, slight to mild irritation was observed 24 hours after removal of the undiluted test material. This reaction was reversible in one animal after 3 days and after 5 days in the remaining two animals. The author of the report concludes that the test material is a slight to mild irritant, however, the recorded irritation was not sufficient for classification in accordance with CLP; the test material is therefore determined to be not irritating.

A further supporting study was performed on the substance to be registered (at a purity of 80 %), Rush (1991). In the primary dermal irritation study, 6 young adult New Zealand white rabbits were dermally exposed to 0.5 mL of the test material for 24 hours.  Animals then were observed for 72 hours and the study was terminated before full reversibility could be determined. Irritation was scored by the method of Draize. Under the conditions of the test, the test substance was not a dermal irritant.

The remaining seven supporting studies were performed using two read across substances. All read-across studies demonstrate that these categories of substances are not dermal irritants.

Eye Irritation:

The eye irritation dataset contains three studies performed using the substance to be registered and seven performed on read across substances.

In the key study, Mallory (1986), the irritation potential of the substance to be registered was determined in an acute eye irritation study performed under GLP conditions and followed a protocol similar to that of OECD 405. The test material was instilled into the right eye of 6 New Zealand white rabbits (3 male and 3 female). The eye was examined at 1, 24, 48, 72 hours after administration and scored for ocular irritation in accordance with the Draize scale (1965). Due to the absence of irritation at 72 hours the study was terminated. Under the conditions of the test, animals displayed mild discomfort immediately following application of the test material. One hour after application there was moderate discharge, mild swelling and redness, and slight iris congestion. Edema and corneal dullness increased by 24 hours. Following irrigation 24 hours post application, congestion reduced so that iris clarity was practically normal by day 5. Based on these results the author of the report concludes that the test material is an eye irritant. However, the observed reactions were mild and not sufficient for classification as an irritant under Regulation (EC) No. 1272/2008.

Two further studies on the material to be registered have been provided as supporting data. The first study, Mallory (1999), was conducted using a 60 % solution in an acute eye irritation study performed under GLP conditions and followed a protocol similar to of OECD 405. Under the conditions of the test, three of the six animals displayed reactions at the 24, 48 and 72 hour time points. The mean scores for corneal opacity, iris, conjunctivae redness and chemosis at these time points was mild. Since the substance was tested in a 60 % solution the results are unreliable and not sufficient for classification in accordance with Regulation (EC) No. 1272/2008. The second study, Younger (1996), was performed in accordance with generally accepted scientific principles, but was presented as an abstract and thus the reliability of the data could not be assessed. Under the conditions of the test, animals displayed mild discomfort immediately following application of the test material. One hour after application there was moderate discharge, mild swelling and redness, and slight iris congestion. Edema and corneal dullness increased by 24 hours. Following irrigation 24 hours post application, congestion reduced so that iris clarity was practically normal by day 5. Based on these results the author of the report concludes that the test material is a mild eye irritant. The results are insufficient to determine a classification in accordance with Regulation (EC) No. 1272/2008.

Data from the studies conducted using the substance to be registered have demonstrated that the test material does not elicit eye irritation at a level that requires classification.

 

Five further supporting studies have been provided on read-across substances.

The results from the three studies conducted using the substance to be registered clearly demonstrated that the test material is not an eye irritant sufficient for classification in accordance with Regulation (EC) No. 1272/2008.


Justification for selection of skin irritation / corrosion endpoint:
The skin irritation dataset contains two studies performed using the substance to be registered and a further seven studies performed on read across substances.
Younger (1966) has been selected as the key study in addressing this endpoint, since the study was performed using the substance to be registered in an undiluted form. The study was performed in accordance with generally accepted scientific principles and presented as a short abstract, with adequate reporting of the methodology and results to allow the reliability of the results to be assessed. Based on the available information, the study can be considered reliable, but with restrictions (Klimisch 2) in accordance with Klimisch et al. (1997).
A further supporting study was performed on the substance to be registered, Rush (1991). This study was conducted to guidelines and GLP; however, the test material was only 80 % pure with the remaining 20 % comprised of a similar calcium sulphonate that is a known skin irritant. The test period was 24 hours instead of 4 hours, representing a worst case scenario. The test ended at 72 hours before full reversibility could be determined.
The remaining seven studies were performed using two read across substances and have been provided as supporting data.

Justification for selection of eye irritation endpoint:
The eye irritation dataset contains three studies performed using the substance to be registered and seven performed on read across substances.
Mallory (1986) has been selected as the key study in addressing this endpoint, since the study was performed using the substance to be registered in an undiluted form. The study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. The study was assigned a reliability score of 2 (reliable with restrictions) in accordance with Klimisch et al. (1997).
Two further supporting studies were performed on the substance to be registered. The first study, Mallory (1999), was conducted using a 60 % solution and is thus not suitable for classification. The study was assigned a reliability score of 3 (not reliable) in accordance with Klimisch et al. (1997). The second supporting study by Younger (1996), was performed in accordance with generally accepted scientific principles, but was presented as an abstract and thus the reliability of the data could not be assessed. The study was therefore assigned a reliability score of 4 (not assignable) in accordance with Klimisch et al. (1997).
The remaining five studies were performed using two read across substances and have been provided as supporting data.

Justification for classification or non-classification

Skin Irritation:

According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification as a skin irritant.

Eye Irritation:

According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification as an eye irritant.