Registration Dossier
Registration Dossier
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EC number: 204-825-9 | CAS number: 127-18-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 138 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Based on SCOEL assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 275 mg/m³
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Based on SCOEL assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 39.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Derived from SCOEL OEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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
Skin irritation and skin sensitisation (proposed classification with R38 and R43)
Tetrachloroethylene is proposed to be classified as a skin irritating and skin sensitising substance. However, it is not possible to derive a DNEL based on the available data. According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoint. In order to guarantee ‘adequately control of risks’, it is necessary to stipulate risk management measures that prevent dermal exposure that will cause skin irritation and skin sensitisation.
Workers exposure
In Appendix R.8-13 of the Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health (May 2008, ECHA) it is noted that:
‘When an EU IOEL exists the registrant may, under conditions as described below, use the IOEL in place of developing a DNEL. A registrant is allowed to use an IOEL as a DNEL for the same exposure route and duration, unless new scientific information that he has obtained in fulfilling his obligations under REACH does not support the use of the IOEL for this purpose. This could be because the information obtained is more recent than the information that was used to support setting the IOEL at EU level and because it leads to another value being derived which requires different risk management measures (RMMs) and operational conditions (OCs)’.
The SCOEL has derived an 8-hour TWA for tetrachloroethylene of 20 ppm and a STEL of 40 ppm (SCOEL/SUM/133, February 2008) (attached at section 13 of the IUCLID for reference). Signs of CNS depression, such as unconsciousness and narcosis, have commonly been reported after acute exposure to tetrachloroethylene. Two human volunteer studies are considered to be sufficiently robust to be taken used for DNEL derivation. Based on these studies, a LOAEC of 100 ppm (690 mg/m3) (7 hours exposure) and a NOAEC of 106 ppm (1 hour exposure) are derived. The SCOEL recommends based on these data a STEL of 40 ppm (275 mg/m3). Regarding long-term exposure, there is a relatively large amount of information on the potential repeated dose effects of tetrachloroethylene from studies in humans and from inhalation and oral studies in animals. The critical effects of tetrachloroethylene are kidney, liver and central nervous system effects. The SCOEL concludes that there is no clear evidence from studies in humans for repeated dose effects of tetrachloroethylene at exposure levels up to a level of 20 ppm (138 mg/m3) (8 hr TWA).
Worker-DNEL long-term for the inhalation route:
The 8 hours TWA derived by the SCOEL will be used as DNEL for long-term inhalation exposure: 20 ppm (138 mg/m3).
Worker-DNEL short-term for the inhalation route:
It has been proposed to label tetrachloroethylene with R67 (vapours may cause drowsiness). To protect workers and professional for short term effects via inhalation, theSTEL derived by the SCOEL will be used as DNEL for acute inhalation exposure: 40 ppm (275 mg/m3) for an exposure duration of 15 minutes.
Worker-DNEL long-term for the dermal route
To arrive at a long-term value for the dermal route for workers, route to route extrapolation will be applied starting with the inhalation long-term value of the SCOEL:
138 mg/m3* [100/50] (a) * 10 m3(b) / 70 kg (c) =39.4 mg/kg bw/day
(a) correction for absorption;
(b) 8-hour respiratory volume for workers
(c) body weight for workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: WHO chronic limit for the general population
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.38 mg/m³
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: AFFSET short-term limit for the general population
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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:
- 0.167 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.3 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):
- 210
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 390 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Skin irritation and skin sensitisation (proposed classification with R38 and R43)
Tetrachloroethylene is proposed to be classified as a skin irritating and skin sensitising substance. However, it is not possible to derive a DNEL based on the available data. According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoint. In order to guarantee ‘adequately control of risks’, it is necessary to stipulate risk management measures that prevent dermal exposure that will cause skin irritation and skin sensitisation.
General population-DNEL for the inhalation route:
For the long-term inhalation general population DNEL, the AFFSET (2009)/WHO (2010) limit of 0.25 mg/m3 (60 ppb) has been used. This is based on an LOAEL of 103 mg/m3 for kidney effects in humans (Lauwerys R.et al, 1983). This was adjusted for continuous exposure by dividing by a factor of 168/40. Further, factors of 10 for use of a LOAEL and 10 for intra-species variation were incorporated, leading to a guideline value of 0.25 mg/m3. For the short-term inhalation general population DNEL, the short-term limit of 1.38 mg/m3 (0.2 ppm) has been used, as derived by AFFSET (2009) and ATSDR (1997). It should be noted that these general population DNELs are provided to calculate the RCRs for man indirectly exposed to tetrachloroethylene via the environment. There are no supported consumer uses of tetrachloroethylene.
Reference: Lauwerys R,et al, Health surveillance of workers exposed to tetrachloroethylene in dry-cleaning shops. International Archives of Occupational and Environmental Health.1983; 52:69–77.
General population-DNEL long-term for the dermal route:
To arrive at a long-term value for the dermal route for the general population, route to route extrapolation will be applied starting with the inhalation long-term value calculated for the general population:
0.25 mg/m3* [100/50] (a) * 20 m3 (b) / 60 kg (c) = 0.167 mg/kg bw/day
(a) correction for absorption;
(b) 24 hour respiratory volume for the general population (to calculate the internal dose corresponding to 24 hour exposure)
(c) body weight for the general population
General population-DNEL long-term for the oral route:
To arrive at a long-term value for the oral route for the general population, the chronic oral study in mice was used, which has an LOAEL of 390 mg/kg bw/day:
390 mg/kg bw/day / [5/7] (a) /3 (b) / 7 (c) / 10 (d) / 60 kg (e) = 1.3 mg/kg bw/day
(a) correction for duration (from 5 to 7 days)
(b) correction from LOAEL to NOAEL
(c) correction for allometric factor (mouse)
(d) correction for intra-species differences
(e) body weight for the general population
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