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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Dermal Systemic effects:

An acute dermal toxicity study was conducted to assess the toxic potential of Sakuralube S-900 when applied to skin. Even when dosed at the guideline limit dose (2000 mg/kg), no deaths were recorded and no evidence of systemic toxicity was seen either as clinical signs or during a macroscopic pathological examination. 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. On the basis of this study it is considered that Sakuralube S-900 did not cause any systemic toxicity following dermal dosing, and therefore does not present any hazard by this route.

Dermal Local effects:

A dermal irritation study was conducted to assess the irritancy potential of Sakuralube S-900 to the skin of rabbits.A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and very slight to slight oedema. Other skin reactions noted were crust formation and moderate desquamation. The test material produced a primary irritation index of 3.2 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.The results of this test have resulted in a classification as Skin Irritant 2.

 

Oral toxicity data:

An acute oral toxicity study was conducted to assess the toxic potential of Sakuralube S-900 when ingested. Even when dosed at the guideline limit dose (2000 mg/kg), no deaths were recorded and no evidence of systemic toxicity was seen either as clinical signs or during a macroscopic pathological examination. A repeat dose toxicity study and a separate reproductive toxicity screening study were also conducted using oral dosing; again no deaths related to treatment 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 Sakuralube S-900 did not cause any localised or systemic toxicity following oral dosing, and therefore does not present any hazard by this route. NOAELs were derived at the highest dose of 1000 mg/kg body weight/day.

Inhalation local and systemic effects

Sakuralube S-900 is a dark brown paste/viscous liquid with a high boiling point (515 ±0.5K) and a very low vapour pressure (2.0x10-20Pa at 25°C), therefore it is considered that exposure via the inhalation route is unlikely to occur.No inhalation studies were performed. Acute oral and dermal studies and a repeat dose toxicity study administered by the oral route did not record any signs of systemic toxicity caused by the test material.

Hazard for the eyes:

An in-vivo eye irritation study was conducted to assess the effect of instillation of Sakuralube S-900 in the eyes of Rabbits. No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in all treated eyes at the 1-hour observation, 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 Sakuralube S-900 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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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

Oral toxicity data:

An acute oral toxicity study was conducted to assess the toxic potential of Sakuralube S-900 when ingested. Even when dosed at the guideline limit dose (2000 mg/kg), no deaths were recorded and no evidence of systemic toxicity was seen either as clinical signs or during a macroscopic pathological examination. A repeat dose toxicity study and a separate reproductive toxicity screening study were also conducted using oral dosing; again no deaths related to treatment 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 Sakuralube S-900 did not cause any localised or systemic toxicity following oral dosing, and therefore does not present any hazard by this route. NOAELs were derived at the highest dose of 1000 mg/kg body weight/d.

Dermal Systemic effects:

An acute dermal toxicity study was conducted to assess the toxic potential of Sakuralube S-900 when applied to skin. Even when dosed at the guideline limit dose (2000 mg/kg), no deaths were recorded and no evidence of systemic toxicity was seen either as clinical signs or during a macroscopic pathological examination. 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. On the basis of this study it is considered that Sakuralube S-900 did not cause any systemic toxicity following dermal dosing, and therefore does not present any hazard by this route.

Dermal Local effects:

A dermal irritation study was conducted to assess the irritancy potential of Sakuralube S-900 to the skin of rabbits.A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and very slight to slight oedema. Other skin reactions noted were crust formation and moderate desquamation. The test material produced a primary irritation index of 3.2 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.The results of this test have resulted in a classification as Skin Irritant 2.

 

Inhalation local and systemic effects

Sakuralube S-900 is a dark brown paste/viscous liquid with a high boiling point (515 ±0.5K) and a very low vapour pressure (2.0x10-20Pa at 25°C), therefore it is considered that exposure via the inhalation route is unlikely to occur.No inhalation studies were performed. Acute oral and dermal studies and a repeat dose toxicity study administered by the oral route did not record any signs of systemic toxicity caused by the test material.

Hazard for the eyes:

An in-vivo eye irritation study was conducted to assess the effect of instillation of Sakuralube S-900 in the eyes of Rabbits. No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in all treated eyes at the 1-hour observation, 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 Sakuralube S-900 does not present a hazard to the eyes.