Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:
Inhalation study not available.
AF for differences in duration of exposure:
2
Justification:
Subchronic study
AF for intraspecies differences:
3
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

For workers, relevant routes of exposure to the submission substance include dermal and inhalation . The physical and chemical properties of the substance limit inhalation exposures to aerosols or droplets of inhalable size only under certain use conditions.

 

No acute hazards leading to acute toxicity have been identified for the submission substance by any route of exposure based on the available data. The skin and eye irritation potential of the submission substance is minimal and the substance is not believed to be a skin sensitizer. There is no evidence of local irritation or systemic effects following long-term exposure. All available data indicate the submission substance is not genotoxic, it is not expected to be carcinogenic, and it is not expected to present a reproductive or developmental toxicity hazard. Based on all of the available data, the submission substance was considered to be effectively non-hazardous for all required endpoints. Since classification is not warranted for these endpoints the following DNELS were not calculated for workers:

1) Acute/short-term exposure-systemic effects dermal

2) Acute/short-term exposure-systemic effects inhalation

3) Acute/short-term exposure-local effects dermal

4) Acute/short-term exposure-local effects inhalation

5) Long-term exposure-local effects dermal

6) Long-term exposure-local effects inhalation

7) Long-term exposure-systemic effects dermal

 

Repeated-dose exposures by the oral route to a structural analogue resulted in minimal systemic effects including changes in serum chemistry parameters and changes in relative organ weights including the kidney and liver. However, these changes were not indicative of significant toxicity and occurred at doses above the CLP (EC Regulation 1272/2008) guidance values for classification. Based on these data, the submission substance was considered to be effectively non-hazardous for these endpoints and no classification is warranted. Regardless, a long-term exposure-systemic worker DNEL for both the inhalation route was calculated based on these data. The DNEL was calculated in accordance with REACH regulations and the ECHA guidance document 'Guidance on Information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health' (2008).  All default values used in the calculations were obtained from this document. Assessment factor determinations followed the European Centre for Ecotoxicology and Toxicology of Chemicals recommendations (ECETOC Derivation of assessment factors for human health risk assessment. Technical Report No. 86, 2003).

8) No repeated dose inhalation data were available for this substance. Therefore, a NOAEL of 34mg/kg-bw/day from a 90d repeated-dose oral toxicity study on the structural analogue reaction products of 1-hexadecene with naphthalene was used to calculate the long-term exposure-systemic effects inhalation DNEL. The starting NOAEL was first modified into a corrected inhalatory NOAEC for workers according to ECHA guidance (ECHA, 2008) and an assessment factor of 6 was applied (intraspecies=3; study duration=2).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.85 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
5
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

For the general population, relevant routes of exposure include dermal and limited oral exposures. The physical and chemical properties of the substance limit inhalation exposures to aerosols or droplets of inhalable size only under certain use conditions. The general population is not anticipated to be subject to these uses and therefore is not subject to these types of exposures. In accordance with REACH (Annex I, 1.4.1) DNELS shall be established for the substance reflecting the likely route(s) of exposure. Therefore the following DNELS were not calculated for the general population:

1) Acute/short-term exposure-systemic effects inhalation

2) Long-term exposure-systemic effects inhalation

3) Acute/short-term exposure-local effects inhalation

4) Long-term exposure-local effects inhalation

5) Long-term exposure-systemic effects dermal

No acute hazards leading to acute toxicity have been identified for the submission substance by any route of exposure.  The skin and eye irritation potential of the submission substance is negligible.  There is no evidence of local irritation following long-term exposures. All available data indicate the submission substance is not genotoxic, it is not expected to be carcinogenic, and it is not expected to present a reproductive or developmental toxicity hazard. Based on the available data, the submission substance was considered to be effectively non-hazardous for these endpoints. Since classification is not warranted for these endpoints the following DNELS were also not calculated for the general population:

6) Acute/short-term exposure-systemic effects dermal

7) Acute/short-term exposure-systemic effects oral

8) Acute/short-term exposure-local effects dermal

9) Long-term exposure-local effects dermal

 

Repeated-dose exposures by the oral route to a structural analogue resulted in minimal systemic effects including changes in serum chemistry parameters and changes in relative organ weights including the kidney and liver. However, these changes were not indicative of significant toxicity and occurred at doses above the CLP (EC Regulation 1272/2008) guidance values for classification. Based on these data, the submission substance was considered to be effectively non-hazardous for these endpoints and no classification is warranted. Regardless, a long-term exposure-systemic worker DNEL for both the inhalation route was calculated based on these data. The DNEL was calculated in accordance with REACH regulations and the ECHA guidance document 'Guidance on Information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health' (2008).  All default values used in the calculations were obtained from this document. Assessment factor determinations followed the European Centre for Ecotoxicology and Toxicology of Chemicals recommendations (ECETOC Derivation of assessment factors for human health risk assessment. Technical Report No. 86, 2003).

 

 9) Long-term exposure-systemic effects oral- A NOAEL of 34mg/kg-bw/day from a 90d repeated-dose oral toxicity study on the structural analogue reaction products of 1-hexadence and naphthalene was used to calculate this DNEL. No modification of the starting NOAEL was needed, an assessment factor of 40 was applied (interspecies=4; intraspecies=5; study duration=2).