Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The substance is not considered to be irritating the 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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
other: Results from read-across CAS No. 112-60-7.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 15 min
Score:
0
Remarks on result:
other: Results from read-across CAS No. 112-60-7.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 d
Score:
0
Remarks on result:
other: Results from read-across CAS No. 112-60-7.
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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
0
Remarks on result:
other: Result from read-across CAS No. 112-60-7.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no studies available that evaluate the skin and/or eye irritating potential of the substance itself (target, EC 907-131-0). Therefore studies from a structural analogue (TetraEG, CAS 112-60-7) has been used to cover this endpoint.

Skin irritation / corrosion

In a pre-GLP toxicity study, skin irritation potential of TetraEG was assessed with two Vienna-White rabbits. The intact or abraded skin (clipped) of the animals was exposed to 0.5 g of the test substance on an area of 2.5 cm² under occlusive conditions for 20 hours (BASF, 1976). Animals were observed for 8 days. Findings were recorded after 1 min, 5 min, 15 min and 20 hours and at the end of the observation period. After 20-hour exposure a slight reddening (ear) was observed, which was reversible within 8 days. As the overall irritation score was determined to be 0, the substance is not considered to be irritating to the skin.

In a pre-GLP toxicity study, skin irritation potential of TetraEG was assessed with two rabbits. The skin of the animals was exposed to the test substance under occlusive conditions for 20 hours (BASF, 1964). Readings were performed after 24 hours and 8 days. After 20-hour exposure questionable reddening was observed, which was reversible within 8 days. As the overall irritation score was determined to be 0, the substance is not considered to be irritating to the skin.

As TetraEG (CAS 112-60-7) was not considered to be irritating to the skin, the target substance (EC 907-131-0) was also not considered to be irritating to the skin.

Eye irritation

In a pre-GLP toxicity study, eye irritation potential was assessed with two Vienna White rabbits. Animals were exposed to 0.05 mL of TetraEG for 24 hours (BASF, 1976). The untreated eye served as a control. Eyes were examined 1 hour, 24 hours and 8 days after instillation. After 1 and 24 hours, slight reddening was observed, which fully reversed after 8 days. Under the conditions of the test, the test substance was not considered irritating to eyes.

In a pre-GLP toxicity study, eye irritation potential was assessed with two rabbits. Animals were exposed to TetraEG for 24 hours (BASF, 1964). The untreated eye served as a control. Eyes were examined 1 hour, 24 hours and 8 days after instillation. After 1 hour, slight reddening was observed, which fully reversed after 24 hours. Under the conditions of the test, the test substance was not considered irritating to eyes.

As TetraEG (CAS 112-60-7) was not considered to be irritating to the eyes, the target substance (EC 907-131-0) was also not considered to be irritating to the eyes.

Justification for classification or non-classification

Based on the results of the skin and eye irritation tests, the substance does not have to be classified for skin or eye irritation in accordance with Regulation (EC) No. 1272/2008. However, since the substance (EC 907-131-0) contains up to 3% potassium hydroxide (CAS: 1310-58-3) impurity, the test substance has to be classified as Skin Corr. 1B (H314) and Eye Dam. 1 according to the harmonised classification and labelling.