Registration Dossier
Registration Dossier
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EC number: 907-131-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - 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:
- DNEL (Derived No Effect Level)
- Value:
- 33.3 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
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:
- 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:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
No specific toxicology data have been obtained for this reaction mass. The systemic toxicology for this material, however, may be cross-read from structurally overlapping and/or closely related materials such as Tri- and Tetraethylene glycol, which are major parts of this mass, and Polyethylene glycol 200 and 400.
The reaction mass may, dependend on the supplyer, also contain up to 3% NaOH. In that case the material has to be classified as Skin Corr. 1B and the acute local DNEL of NaOH (1 mg/m³; ECHA disseminated dossier, Feb 2023) has to be observed.
The following DNELs were not derived:
Acute systemic inhalation: The reaction mass material needs not to be classified in terms of systemic inhalation toxicity. The LC50 of a related material (Triethylene glycol) was > 5200 mg/m3 (BRRC, 1991). Another related material (PEG 200) showed an LC 50 (6 hrs) of > 2500 mg/m3, the highest feasible concentration (Crook et al., 1981). 500 mg/m3 was the NOAEC in a 9-day inhalation study with TriEG (Ballantyne et al., 2006). There is also no oral toxicity in rats and no significant irritation potential. For TriEG there was a low potential of sensory irritation with an RD 50 in mice of 5140 mg/m3 (Ballantyne et al., 2006).
Long-term systemic inhalation: No adverse findings were obtained in subchronic inhalation studies. The data therefore do not warrant and do not allow to define a DNEL. The doses investigated were very high for all exposure routes: in a 9 days inhalation study (Ballantyne et al., 2006), 1036 mg/m3 showed no exposure-related findings (with the possible exception of a non-statistically significant decrease in female body weight gains). No clinical pathology findings and no ophthalmologic lesions were noted. No further inhalation study of longer duration is deemed necessary; this is supported also by the results of a 90 days inhalation study with polyethylene glycol 200, a mixed material which contains approximately 17 % TriEG and the following closely related materials: 29% TetraEG (29%) and 25% PentaEG. With this material a NOAEC of 1000 mg/m3 has been obtained (Crook et al., 1981). This NOAEC can be reasonably read across to TriEG.
Dermal exposure (acute and chronic; local and systemic): No classification for dermal toxicity is warranted. On the other hand, the material may contain up to 3 % NaOH and in that case is to be classified as corrosive. No data are available which allow to propose a firm chronic DNEL for NaOH.
Oral exposure: No classification for oral toxicity. The repeated dose toxicity has been investigated in oral (gavage) studies. No pronounced effects were noted with TetraEG in the course of a 28-day study with doses up to 2000 mg/kg bw/day (Schladt et. al., 1998) or in a 90-day study with PEG 400 (Hermansky et al., 1995) up to 5640 mg/kg bw/day and a NOAEL of 1128 mg/kg bw/day. Furthermore, there is no designed oral exposure; the reaction mass is not foreseen for an oral uptake in humans
DNEL- long-term, inhalation, local:
The local DNEL has to take into account a possible 3% NaOH content. For NaOH a local long-term DNEL of 1 mg/m³ (ECHA disseminated dossier, Feb 2023) is available, therefore an acute inhalation DNEL of (1 mg/m³ *100%/3% =) 33.3 mg/m³ is proposed on the basis of the NaOH content.
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:
- 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
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
No DNELs for the general population were proposed since there is no designed exposure of the public to this material.
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