Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.