Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Inhalation Systemic effects:

An acute inhalation study indicates a local effect on the lungs, but there were no specific signs of systemic absorption; in addition, a repeat dose toxicity administered by the oral route did not record any signs of systemic toxicity caused by the test material. On this basis it is considered that the substance does not present a hazard for systemic effects following inhalation of BMI.

Inhalation Local effects:

BMI was observed to have caused toxicity in an acute inhalation study; the treatment-related deaths were concluded to have been due to localised toxicity in the lungs. It is assumed that this localised toxicity will present a problem for long-term exposure as well as for short-term or acute exposure. The dose levels assessed in the acute toxicity study were sufficient to identify an LD50, but no No Adverse Effect Level could be established because some of the exposed rats died in the lowest dose level; on this basis a quantitative DNEL cannot be derived. BMI is classified as Acute Toxicity Category 3 for inhalation exposure; in accordance with table E3-1 in the "Guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation" Version 2.0 (ECHA, 2012), this classification corresponds to a medium hazard.

Dermal Systemic effects:

No systemic absorption or distribution of BMI were apparent in the available oral (acute and repeat dose) or inhalation (acute) studies. Although a localised effect was seen on skin contact (see below) there is no information which would indicate significant uptake by skin contact followed by systemic distribution; coupled with the lack of systemic toxicity by inhalation and oral routes, no significant hazard from systemic toxicity following dermal contact is anticipated.

Dermal Local effects:

No dermal toxicity data is available for BMI, however a Guinea Pig Maximisation test determined that BMI may cause dermal sensitisation in exposed individuals. The results of this test have resulted in a classification as Skin Sensitiser Category 1A, indicating significant concern for a sensitising effect. No threshold was determined for sensitisation, and so it is not possible to establish a quantitative DNEL for local dermal effects. Due to the concern for a sensitising effect, BMI is considered to present a high hazard for local dermal effects. Although sensitisation typically occurs over a series of exposures (i.e. long-term or chronic exposure) it cannot be confirmed that a sensitisation effect will not occur over a short period of time, and so this hazard is considered applicable to a short-term or acute exposure as well as to long-term.

Hazard for the eyes:

An in-vivo eye irritation study was conducted to assess the effect of instillation of BMI in the eyes of Rabbits. Some slight conjunctival injection and / or chemosis was observed in some animals treated, but this was observed to fully recover by the end of the post-exposure observation period. The severity of the irritation response observed was not sufficient to trigger a classification under the CLP Regulation; on this basis it is concluded that BMI does not present a hazard to the eyes.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Inhalation Systemic effects:

An acute inhalation study indicates a local effect on the lungs, but there were no specific signs of systemic absorption; in addition, a repeat dose toxicity administered by the oral route did not record any signs of systemic toxicity caused by the test material. On this basis it is considered that the substance does not present a hazard for systemic effects following inhalation of BMI.

Inhalation Local effects:

BMI was observed to have caused toxicity in an acute inhalation study; the treatment-related deaths were concluded to have been due to localised toxicity in the lungs. It is assumed that this localised toxicity will present a problem for long-term exposure as well as for short-term or acute exposure. The dose levels assessed in the acute toxicity study were sufficient to identify an LD50, but no No Adverse Effect Level could be established because some of the exposed rats died in the lowest dose level; on this basis a quantitative DNEL cannot be derived. BMI is classified as Acute Toxicity Category 3 for inhalation exposure; in accordance with table E3-1 in the "Guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation" Version 2.0 (ECHA, 2012), this classification corresponds to a medium hazard.

Dermal Systemic effects:

No systemic absorption or distribution of BMI were apparent in the available oral (acute and repeat dose) or inhalation (acute) studies. Although a localised effect was seen on skin contact (see below) there is no information which would indicate significant uptake by skin contact followed by systemic distribution; coupled with the lack of systemic toxicity by inhalation and oral routes, no significant hazard from systemic toxicity following dermal contact is anticipated.

Dermal Local effects:

No dermal toxicity data is available for BMI, however a Guinea Pig Maximisation test determined that BMI may cause dermal sensitisation in exposed individuals. The results of this test have resulted in a classification as Skin Sensitiser Category 1A, indicating significant concern for a sensitising effect. No threshold was determined for sensitisation, and so it is not possible to establish a quantitative DNEL for local dermal effects. Due to the concern for a sensitising effect, BMI is considered to present a high hazard for local dermal effects. Although sensitisation typically occurs over a series of exposures (i.e. long-term or chronic exposure) it cannot be confirmed that a sensitisation effect will not occur over a short period of time, and so this hazard is considered applicable to a short-term or acute exposure as well as to long-term.

Oral effects:

An acute oral toxicity was conducted to assess the toxic potential of BMI when ingested. Even when dosed at the guideline limit dose (2000 mg/kg), no deaths were recorded and no evidence of systemic toxicity were seen either as clinical signs or during a macroscopic pathological examination. A repeat dose toxicity study screening study (incorporating a reproductive toxicity screen) was also conducted using oral dosing; again no deaths were recorded in any of the treated animals, and no signs of systemic or local toxicity were observed either during the in-life phase of the study, or in the post mortem examinations. On the basis of these two studies it is considered that BMI did not cause any localised or systemic toxicity following oral dosing, and therefore does not present any hazard by this route.

Hazard for the eyes:

An in-vivo eye irritation study was conducted to assess the effect of instillation of BMI in the eyes of Rabbits. Some slight conjunctival injection and / or chemosis was observed in some animals treated, but this was observed to fully recover by the end of the post-exposure observation period. The severity of the irritation response observed was not sufficient to trigger a classification under the CLP Regulation; on this basis it is concluded that BMI does not present a hazard to the eyes.