Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
161.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
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:
DNEL (Derived No Effect Level)
Value:
12.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11 800 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Acute/short term exposure – systemic effects

According to ECHA Guidance on information requirements and CSR, chapter R8, a DNEL for acute systemic toxicity should be derived only if an acute systemic toxicity hazard leading to C&L has been identified. Geraniol is not subject to classification and labelling and consequently the establishment of DNELs for acute/short-term exposure - systemic effects is not required.

Acute/short term and long term exposure – local effects

Geraniol is a skin and eye irritant and hence subjected to classification as R38 and R41 according to Directive 67/548/EEC and skin and eye damage Cat 2 / H 315 and Cat 1/ H 318 (Causes skin irritation and Causes serious eye damage), respectively, according to Regulation 1272/2008/EC. No experimental data are available addressing local effects in the repsiratory tract. Furthermore, Geraniol is a skin sensitiser and hence subjected to classification as R43 according to Directive 67/548/EEC and skin sens. Cat 1 / H317 (May cause an allergic skin reaction) according to Regulation 1272/2008/EC. Since sensitising reactions occur also at not irritating concentrations, this endpoint was chosen as most sensitive. The RIFM Expert Panel reviewed the critical effect data for geraniol and, based on the weight of evidence, established the No Expected Sensitization Induction Level (NESIL) as 11800 μg/cm². This concentration protects also against (skin) irritation, meaning the NESIL covers both, short and long term local effects.

Long-term exposure - systemic effects

The dermal DNEL for long-term exposure is derived from the no observed effect level in a dermal screening study for reproduction and developmental toxicity. The NOAEL was 300 mg/kg bw/d (BASF SE, 2010).

The inhalation DNEL for long-term exposure is derived from the no observed effect level in an oral 112–day repeated dose toxicity study. A NOAEL of 550 mg/kg bw/day was estimated (Hagan, 1967).

 

Starting point for dermal exposure: dermal screening study for reproduction and developmental toxicity: NOAEL = 300 mg/kg bw/d

Assessment factors for dermal DNEL:

- interspecies (rat -> human):                                4

- intraspecies (acc. to ECETOC TR 86):              3

- exposure duration (subchronic -> chronic):        2

=> overall:                                                        24

Since the study was conducted via dermal exposure, no route to route extrapolation factor is needed.

Starting point for inhalation exposure: oral 112 -day study, NOAEL = 550 mg/kg bw/d

Corrected starting point for inhalation: NOAC = NOAEL * 1/0.38 * 6.7/10 = 969,7 mg/m³(8h)

Assessment factors for inhalation DNEL:

- intraspecies (acc. to ECETOC TR 86):        3

- exposure duration (subchronic -> chronic):    2

=> overall:                                                     6

Since the molecule is relatively small and very soluble, it is assumed that 100% of the substance is resorbed by the body when administered per gavage. Hence, no additional assessment factor for route to route extrapolation (oral -> inhalation) is needed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
47.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
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:
DNEL (Derived No Effect Level)
Value:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11 800 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Acute/short term exposure – systemic effects

According to ECHA Guidance on information requirements and CSR, chapter R8, a DNEL for acute systemic toxicity should be derived only if an acute systemic toxicity hazard leading to C&L has been identified. Geraniol is not subject to classification and labelling and consequently the establishment of DNELs for acute/short-term exposure - systemic effects is not required.

Acute/short term and long term exposure – local effects

Geraniol is a skin and eye irritant and hence subjected to classification as R38 and R41 according to Directive 67/548/EEC and skin and eye damage Cat 2 / H 315 and Cat 1/ H 318 (Causes skin irritation and Causes serious eye damage), respectively, according to Regulation 1272/2008/EC. No experimental data are available addressing local effects in the repsiratory tract. Furthermore, Geraniol is a skin sensitiser and hence subjected to classification as R43 according to Directive 67/548/EEC and skin sens. Cat 1 / H317 (May cause an allergic skin reaction) according to Regulation 1272/2008/EC. Since sensitising reactions occur also at not irritating concentrations, this endpoint was chosen as most sensitive. The RIFM Expert Panel reviewed the critical effect data for geraniol and, based on the weight of evidence, established the No Expected Sensitization Induction Level (NESIL) as 11800 μg/cm². This concentration protects also against (skin) irritation, meaning the NESIL covers both, short and long term local effects.

Long-term exposure - systemic effects

The dermal DNEL for long-term exposure is derived from the no observed effect level in a dermal screening study for reproduction and developmental toxicity. The NOAEL was 300 mg/kg bw/d (BASF SE, 2010).

The oral and the inhalation DNELs for long-term exposure are derived from the no observed effect level in an oral 112–day repeated dose toxicity study. A NOAEL of 550 mg/kg bw/day was estimated (Hagan, 1967).

 

Starting point for dermal exposure: dermal screening study for reproduction and developmental toxicity: NOAEL = 300 mg/kg bw/d

Assessment factors for dermal DNELs:

- interspecies (rat -> human):                                4

- intraspecies (acc. to ECETOC TR 86):              5

- exposure duration (subchronic -> chronic):         2

=> overall dermal:                                            40

Since the study was conducted via dermal exposure, no route to route extrapolation factor is needed.

Starting point for oral and inhalation exposure: oral 112 -day study, NOAEL = 550 mg/kg bw/d

Assessment factors for oral DNEL:

- interspecies (rat -> human):                                4

- intraspecies (acc. to ECETOC TR 86):              5

- exposure duration (subchronic -> chronic):         2

=>overall oral:                                                  40

Corrected starting point for inhalation: NOAC = NOAEL * 1/1.15 = 478.3 mg/m³ (24h)

Assessment factors for inhalation DNEL:

- intraspecies (acc. to ECETOC TR 86):         5

- exposure duration (subchronic -> chronic):        2

=> overall:                                                      10

Since the molecule is relatively small and very soluble, it is assumed that 100% of the substance is resorbed by the body when administered per gavage. Hence, no additional assessment factor for route to route extrapolation (oral -> inhalation) is needed.