Registration Dossier
Registration Dossier
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EC number: 930-936-3 | CAS number: -
Toxicological Summary
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
- Route of original study:
- Oral
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:
Lack of inhalation study. Assume equal bioavailability by oral or inhalation routes
- 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:
- 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:
- 5.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 24
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for intraspecies differences:
- 3
- Justification:
- ECHA default
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 study 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 study substance by any route of exposure. The skin and eye irritation potential of the study substance is negligible. There is no evidence of local irritation following long-term exposure. All available data indicate the study substance is not genotoxic and it is not expected to be carcinogenic. Based on the available data, the study substance was considered to be effectively non-hazardous for these 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
Repeated-dose exposures by both the oral and dermal routes to the study substance 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 study substance was considered to be effectively non-hazardous for these endpoints and no classification is warranted. Regardless, long-term exposure-systemic worker DNELS for both the inhalation and dermal routes were calculated based on these data. DNELs were 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).
7) A NOAEL of 125 mg/kg-bw/day from a 90d repeated-dose dermal toxicity study was used to calculate the long-term exposure-systemic effects dermal DNEL. Dosimetric exposure adjustments were not necessary, an assessment factor of 24 was applied (interspecies=4; intraspecies=3; study duration=2)
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 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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
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
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
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 study 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 study 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
No acute hazards leading to acute toxicity have been identified for the study substance by any route of exposure. The skin and eye irritation potential of the study substance is negligible. There is no evidence of local irritation following long-term exposures. All available data indicate the study substance is not genotoxic and it is not expected to be carcinogenic. Based on the available data, the study 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:
5) Acute/short-term exposure-systemic effects dermal
6) Acute/short-term exposure-systemic effects oral
7) Acute/short-term exposure-local effects dermal
8) Long-term exposure-local effects dermal
Repeat-dose exposures by both the oral and dermal routes to the study substance 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 study substance was considered to be effectively non-hazardous for these endpoints and no classification is warranted. Regardless, long-term exposure-systemic DNELS for both the oral and dermal routes were calculated for the general population. DNELs were 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 dermal -A NOAEL of 125mg/kg-bw/day from a 90d repeated-dose dermal toxicity study was used to calculate the DNEL. A dosimetric exposure adjustment was necessary to correct for a seven day daily dose for the general population from the five day experimental dosing paradigm, an assessment factor of 40 was applied (interspecies=4; intraspecies=5; study duration=2).
10) Long-term exposure-systemic effects oral- A NOAEL of 34mg/kg-bw/day from a 90d repeated-dose oral toxicity study 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).
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