Registration Dossier
Registration Dossier
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EC number: 289-348-4 | CAS number: 87788-32-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.88 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The toxicity of (μ(5-amino-1,3,3-trimethylcycloihexylamine-N,N')hexafluorodiboron was investigated the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and was designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996).
This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 25 mg/kg bw/day.
The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 100 mg/kg bw/day. Therefore,NOAEC is ((100/2)/(1/0.38))*0.67 = 88.2 mg/m3
Since only a sub-chronic oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation routes. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route specific information on the starting route, to include a default factor of 2 in the case of oral-inhalation extrapolation. On the assumption, that in general, dermal absorption will not be higher than oral absorption, no default factor is introduced for the oral to dermal extrapolation. The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation.
This approach will be taken forward to DNEL derivation.
- AF for differences in duration of exposure:
- 2
- Justification:
- Duration of exposure is based on an OECD 422 study and therefore an assessment factor for duration extrapolation of 2 has been applied (e.g subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Derived endpoint is based on a laboratory Rat study and therefore an allometric scaling factor of 4 has been applied in accordance with Table R. 8-3 Allometric scaling factors for different species as compared to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor applied for interspecies differences e.g. remaining differences Table R.8.6 Default Assessment factors
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor applied for intraspecies differences for worker population
- Justification:
- Not required
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute/short term - systemic effects Worker DNEL is necessary because the DNEL Worker long-term systemic effects is sufficient for protection.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The acute dermal LD50 (μ(5-amino-1,3,3-trimethylcycloihexylamine-N,N')hexafluorodiboron in rats of both sexes observed in an OECD 402 Acute Dermal study and determined to be greater than 2000 mg/kg, The test material has therefore practically no acute toxicity to the rat by this route of application. Skin irritation was also not observed. As a long term dermal toxicity study is not available the oral reproductive toxicity endpoint determined using a the OECD Guidelines for Test.
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor is introduced for the oral to dermal extrapolation. The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation. However, based on the log Kow of -2.34 and molecular weight of the substance (305.9), the skin permeability according to Fitzpatrick et al (2004) of the substance is considered to be marginally permeable to the skin based on a calculated Log skin permeation coefficient of -7.42. Therefore, a ratio of 0.5 for oral to dermal absorption is provisonally suggested for DNEL derivation.
- AF for differences in duration of exposure:
- 2
- Justification:
- Duration of exposure is based on an OECD 422 study and therefore an assessment factor for duration extrapolation of 6 has been applied (e.g subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default assessment factor applied for interspecies differences e.g. remaining differences Table R.8.6 Default Assessment factors
- AF for other interspecies differences:
- 4
- Justification:
- Derived endpoint is based on a laboratory Rat study and therefore an allometric scaling factor of 4 has been applied in accordance with Table R. 8-3 Allometric scaling factors for different species as compared to humans
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor applied for intraspecies differences for worker population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute/short term - systemic effects Worker DNEL is necessary because the DNEL Worker long-term-systemic effects is sufficient for protection.
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
According to REACH “Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment”, above 10t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, acute DNELs should default the long-term systemic DNELs.
For local effects, a DNEL was not quantifiable; However, as the substance is known to be a skin sensitizer, local effects must be assessed qualitatively and risk management measures applied as necessary. The potential for
respiratory sensitization is unknown; however, given its skin sensitization potential, this endpoint should also be assessed qualitatively.
The dose descriptor starting point for DNEL calculation used:
NOAEL: 100 mg/kg bw (determined during an OECD 422 in rats performed in 2017/18).
Dermal absorption was based on the substance being marginally permeable to skin considered to be 50%.
For inhalation, a corrected NAEC human of 88.2 mg/m3 was used
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
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
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
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:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
