Registration Dossier

Administrative data

Description of key information

The oral LD50 was determined to be > 9790.3 mg/kg bw.

The inhalation LC50 (4h) was determined to be > 5.2 mg/L .

The dermal LD50 was determined to be > 15678.53 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 790.37 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result from read-across source CAS No. 112-60-7.
Remarks:
Correction for molecular weight was applied.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 872.71 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result from read-across source CAS No. 112-60-7.
Remarks:
Correction for molecular weight was applied.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
9 790.37 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.2 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Result from read across CAS 112-27-6
Remarks:
No correction for molecular weight was applied.
Sex:
male/female
Dose descriptor:
LC50
Remarks:
rat
Effect level:
> 2 128.3 mg/m³ air
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Result from read across CAS 25322-68-3
Remarks:
Correction for molecular weight was applied.
Sex:
male/female
Dose descriptor:
LC50
Remarks:
mouse
Effect level:
> 2 128.3 mg/m³ air
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Result from read across CAS 25322-68-3
Remarks:
Correction for molecular weight was applied
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
5 200 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 678.53 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Result from read across (CAS 112-60-7).
Remarks:
Correction for molecular weight was applied.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
15 678.53 mg/kg bw

Additional information

There is are no studies available on the acute toxicity of the substance itself (target, EC 907-131-0). Therefore studies from three structural analogues (TEG, TetraEG, PEG 200) have been used to cover this endpoint.

 

Acute oral toxicity

In a non-GLP acute oral toxicity study performed with rats, groups of male and female animals were treated with TetraEG (CAS 112-60-7) by gavage (BASF, 1976). The rats were exposed to a single dose of 10000 µL/kg (equivalent to 11240 mg/kg bw) following a 14 day post-treatment observation period. No clinical signs or changes in body weight were observed. No mortality occurred. The LD50 was determined to be >10000 µL/kg (which is equivalent to >11240 mg/kg bw). After molecular weight correction the LD50 for the target substance (EC 907-131-0) was determined to be > 9790.37 mg/kg bw.

 

In a non-GLP acute oral toxicity study performed with rats, animals were treated with TetraEG (CAS 112-60-7) by gavage (BASF, 1964). The rats were exposed to single dose of 2150 mg/kg bw following a 7 day post-treatment observation period. No clinical signs or changes in body weight were observed. No mortality occurred. After molecular weight correction the LD50 for the target substance (EC 907-131-0) was determined to be > 1872.71 mg/kg bw.

 

Acute inhalation toxicity

In a GLP-compliant acute inhalation study (BRRC, 1991) performed with Sprague-Dawley rats, 5 male and 5 female animals were exposed whole body to a TEG (CAS 112-27-6) aerosol of 5.2 mg/L for 4 hours. No mortalities were reported. Clinical signs found were periocular wetness, blepharospasm wet (oily) fur, absence of toe and tail pinch reflexes. Unkempt fur was the only sign observed during the post-exposure period. No macroscopic lesions were observed in animals sacrificed at the end of the 2-week post-exposure period. The acute inhalative LC50 value was determined to be > 5.2 mg/L for 4 hours. Correction for molecular weight was not applied, therefore the LC50 for the target substance (EC 907-131-0) was also determined to be 5.2 mg/L for 4 hours.

 

In two non-GLP acute inhalatory toxicity studies performed with Fischer 344 rats and B6C3F1 mice, 6 animals/sex per study were exposed whole body to PEG 200 (CAS 25322-68-3) aerosol of 2516 mg/m3 (measured) for 6 hours (CSL, 1981). Inhalation exposure to a high airborne concentration of PEG 200 produced no remarkable acute toxic effects in rats and mice. No mortality was observed. In addition to the non-lethality of the acute PEG 200 exposure, no biologically significant alterations in blood chemistry, haematology, or pulmonary resistance were seen. No mutations or pathological abnormalities could be attributed to PEG 200. The LC50 (6h) of PEG 200 (CAS 25322-68-3) for both rat and mice was determined to be >2516 mg/m3. After molecular weight correction the LC50 (6h) for the target substance (EC 907-131-0) for both rat and mice was determined to be 2128.3 mg/m3.

 

Acute dermal toxicity

In an acute dermal toxicity study equivalent or similar to OECD TG 402, 5 rabbits per sex were dermally exposed for 24 hours to 16 mL/kg bw TetraEG (CAS 112-60-7) under occlusive conditions. Observations for skin reaction were made at one hour, 7 days and 14 days after the contact period. Animal weights are recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice). At death or sacrifice, each animal is subjected to gross pathologic evaluation. In male rabbits, sample residue and oedema were observed at day 1. In females rabbits, sample residue, oedema and erythema were observed on day 1. Male and female rabbits gained weight during the 14 day observation period. There were no treatment related gross pathologic observations in male or female rabbits and no mortality was observed. The LD50 was determined to be > 16 mL/kg bw (equivalent to > 18000 mg/kg bw). After molecular weight correction the LD50 for the target substance (EC 907-131-0) was determined to be > 15678.53 mg/kg bw.

Justification for classification or non-classification

Based on the available information classification for acute toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.