Paraffin oils, sulfochlorinated, saponified

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.81 mg/m³

Most sensitive endpoint:

developmental toxicity / teratogenicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

12.5

Dose descriptor starting point:

LOAEL

Value:

70 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

47.63 mg/m³

Explanation for the modification of the dose descriptor starting point:

LOAEL fetal: 70 mg/kg bw/day (Low Observed Adverse Effect Level)
-> NOAEL = 70/3 = 23.3

Corrected inhalatory NOAEL = (23,3/2.4 (rabbit) x 70/10 x7/5 x50/100 )

NOAEC = 47.63 mg/m³ 

Expose in animal study/exposure in humans = 7/5 (default worker)

AF for dose response relationship:

1

AF for differences in duration of exposure:

1

Justification:

1 (complete organogenese)

AF for interspecies differences (allometric scaling):

1

Justification:

Already covered by correction of starting point.

AF for other interspecies differences:

2.5

Justification:

ECHA default value

AF for intraspecies differences:

5

Justification:

ECHA default value

AF for the quality of the whole database:

1

Justification:

The default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

other: ECHA guidance

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

other: ECHA guidance

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.09 mg/kg bw/day

Most sensitive endpoint:

developmental toxicity / teratogenicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

30

Dose descriptor starting point:

LOAEL

Value:

70 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

32.6 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

LOAEL fetal: 70 mg/kg bw/day (Low Observed Adverse Effect Level)
-> NOAEL = 70/3 = 23.3

Corrected human NOAEL = 32.6 mg/kg (23.3 x 7/5)
Expose in animal study/exposure in humans = 7/5 (default worker)

AF for dose response relationship:

1

Justification:

When the starting point is a NOAEL, the default assessment factor, as a standard procedure, is 1.

AF for differences in duration of exposure:

1

Justification:

1 (complete organogenese)

AF for interspecies differences (allometric scaling):

2.4

Justification:

Default allometric scaling factor for rabbit to human. 2.4 (default)

AF for other interspecies differences:

2.5

Justification:

ECHA suggests a default factor of 2.5 for remaining interspecies differences.

AF for intraspecies differences:

5

Justification:

ECHA default value

AF for the quality of the whole database:

1

Justification:

The default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Local effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

low hazard (no threshold derived)

Additional information - workers

Acute toxicity:

Systemic toxicity:

Acute oral: LD50 1271 mg/kg; non-specific signs of toxicity were observed, including depression, ruffles fur and dyspnoea. The signs tended to persist longer in the higher dosages where animals survived the investigation period. No particular specific effect was noted in the body weight data. Gross necropsy observations were also non-specific in animals at termination. Rats which died during the first few days after dosing showed gastrointestinal lesions and some other congested organs. The cause of death of these animals may have been related to the intestinal lesions. Histopathology was not performed.

 

Local effects:

Acute dermal: Solely irritant potency on skin detected. The same applies for skin and eye irritation studies. The substance is classified with Skin Irrit Cat. 2 (Regulation (EU) 1272/2008); according to ECHA Guidance ECHA Guidance Part E: Risk Characterisation (May 2016) this translates into “low hazard”.

 

Developmental toxicity/teratogenicity:

Systemic toxicity:

LOAEL fetal: 70 mg/kg bw/day (Low Observed Adverse Effect Level)
-> NOAEL = 70/3 = 23.3

Corrected human NOAEC = 47.63 mg/m³ (23,3/2.4 (rabbit) x 70 / 10 x7/5 x50/100)
DNEL (systemic long term) = 3.81 mg/m³ (47.63 / 12.5)
Expose in animal study/exposure in humans = 7/5 (default worker)

 

Local toxicity:

The substance is classified with Skin Irrit Cat. 2 (Regulation (EU) 1272/2008); according to ECHA Guidance ECHA Guidance Part E: Risk Characterisation (May 2016) this translates into “low hazard”.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.68 mg/m³

Most sensitive endpoint:

developmental toxicity / teratogenicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

25

Dose descriptor starting point:

LOAEL

Value:

70 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

17.01 mg/m³

Explanation for the modification of the dose descriptor starting point:

LOAEL fetal: 70 mg/kg bw/day (Low Observed Adverse Effect Level)
-> NOAEL = 70/3 = 23.3

Corrected inhalatory NOAEL = (23.3 / 2.4 x 70 / 20 x 50/100)
NOAEC = 17.01 mg/m³

AF for dose response relationship:

1

AF for differences in duration of exposure:

1

Justification:

1 (complete organogenese)

AF for interspecies differences (allometric scaling):

1

Justification:

Already covered by correction of starting point.

AF for other interspecies differences:

2.5

Justification:

default value

AF for intraspecies differences:

10

Justification:

ECHA guidance

AF for the quality of the whole database:

1

Justification:

The default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.39 mg/kg bw/day

Most sensitive endpoint:

developmental toxicity / teratogenicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

60

Dose descriptor starting point:

LOAEL

Value:

70 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

23.3 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

LOAEL fetal: 70 mg/kg bw/day (Low Observed Adverse Effect Level)
-> NOAEL = 70/3 = 23.3

AF for dose response relationship:

1

Justification:

When the starting point is a NOAEL, the default assessment factor, as a standard procedure, is 1.

AF for differences in duration of exposure:

1

Justification:

1 (complete organogenese)

AF for interspecies differences (allometric scaling):

2.4

Justification:

Default allometric scaling factor for rabbit to human.
2.4 (default)

AF for other interspecies differences:

2.5

Justification:

Echa default value

AF for intraspecies differences:

10

Justification:

ECHA default value

AF for the quality of the whole database:

1

Justification:

The default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Local effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.39 mg/kg bw/day

Most sensitive endpoint:

developmental toxicity / teratogenicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

60

Dose descriptor starting point:

LOAEL

Value:

70 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

23.3 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

LOAEL fetal: 70 mg/kg bw/day (Low Observed Adverse Effect Level)
-> NOAEL = 70/3 = 23.3

AF for dose response relationship:

1

Justification:

When the starting point is a NOAEL, the default assessment factor, as a standard procedure, is 1.

AF for differences in duration of exposure:

1

Justification:

1 (complete organogenese)

AF for interspecies differences (allometric scaling):

2.4

Justification:

Default allometric scaling factor for rabbit to human.
2.4 (default)

AF for other interspecies differences:

2.5

Justification:

default value

AF for intraspecies differences:

10

Justification:

ECHA default value

AF for the quality of the whole database:

1

Justification:

The default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

low hazard (no threshold derived)

Additional information - General Population

Local effects:

Acute dermal: Solely irritant potency on skin detected. The same applies for skin and eye irritation studies. The substance is classified with Skin Irrit Cat. 2 (Regulation (EU) 1272/2008); according to ECHA Guidance ECHA Guidance Part E: Risk Characterisation (May 2016) this translates into “low hazard”.

 

Systemic effects:

See for further details "Additional information for worker"