Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating (based on the data of a dermal acute toxicitiy study (limit test))

Eye irritation: not irritating (OECD 405; GLP compliant)

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)

Additional information

Skin irritation

In accordance with section 8.1 column 2 of REACH Annex VII, an in-vitro skin corrosion study or skin irritation study does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight). An acute dermal toxicity study (limit test) as provided in Section 7.2.3 Acute toxicity: dermal (reference: k_Ullmann_1989) showed no skin irritation during the observation period.

Eye irritation

One reliable animal study described in Ullmann (1989)( OECD 405; GLP complaint) is considered to be reliable without restrictions. The substance was determined not to be irritating to the eyes.

Justification for classification or non-classification

Skin irritation

In accordance with section 8.1 column 2 of REACH Annex VII, an in-vitro skin corrosion study or skin irritation study does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight). An acute dermal toxicity study as provided in Section 7.2.3 Acute toxicity: dermal (reference: k_Ullmann_1989) showed no skin irritation. Thus, antimony trisulfide does not have to be classified for skin corrosion or skin irritation according to regulation (EC) 1272/2008 and subsequent amendments.

Eye irritation

Reference Ullmann (1989) is considered as the key study for in vivo eye irritation and will be used for classification. The mean irritation result (24, 48 and 72 hours) is as follows:

Animal #1:

Cornea score: 0.67 (fully reversible within: 7 days)

Iris score: 0

Conjunctivae score: 2 (fully reversible within: 14 days)

Chemosis score: 1 (fully reversible within: 7 days)

Animal #2:

Cornea score: 0

Iris score: 0

Conjunctivae score: 1 (fully reversible within: 14 days)

Chemosis score: 1 (fully reversible within: 7 days)

Animal #3:

Cornea score: 0

Iris score: 0

Conjunctivae score: 1.33 (fully reversible within: 14 days)

Chemosis score: 1 (fully reversible within: 7 days)

Thus, according to regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes.

Respiratory irritation

Please refer to the discussion under 5.3.3.1 (in the CSR). Furthermore, the classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) and repeated dose toxicity (endpoint 7.5) for further information.