2-(oxolan-2-ylmethoxy)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 - 25 Oct 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

adopted 2002

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(oxolan-2-yl)methoxy]ethan-1-ol

EC Number:

608-659-1

Cas Number:

31692-85-0

Molecular formula:

C5H10O2[C2H4O]n, n = 0, 1, 2, 3, 4, ... (data given for max n of 4)

IUPAC Name:

2-[(oxolan-2-yl)methoxy]ethan-1-ol

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: step 1: 156 - 169 g; step 2: 164 - 178 g
- Fasting period before study: animals were fasted 16 - 19 h prior to administration
- Housing: group-caged in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of approx. 2.8, ad libitum (analysis were performed)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: no information provided in the test report

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no information provided in the test report

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per step (2 steps)

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of dosing animals were observed for general clinical signs, morbidity and mortality at least once during the first 30 min and with more attention during the first 4 h, then once daily. Body weights were determined on Day 1 prior to dosing, on Day 8 and Day 15.
- Necropsy of survivors performed: yes

Statistics:

Mean values and standard deviations were calculated for body weights.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Slightly reduced spontaneous activity, moderate piloerection, hunched posture, slow movements, slight ataxia and prone position were observed in all 6 animals during the first 2 days, but vanished afterwards.

Gross pathology:

No abnormal morphological findings were observed in any animal.

Any other information on results incl. tables

Table 1: Absolute body weights and body weight gain

Step	Animal No.	Starting dose (mg/kg bw)	Body weight (g)			Body weight gain in comparison to Day 1 (%)
			Day 1	Day 8	Day 15
1	1	2000	168	184	199	18
	2		156	185	192	23
	3		169	197	207	22
2	4		173	191	196	13
	5		164	181	196	20
	6		178	206	220	24

Applicant's summary and conclusion

Interpretation of results:

other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

An acute oral toxicity study according to OECD Guideline 423 in rats was performed with the test substance and resulted in a LD50 greater than 2000 mg/kg bw. Thus the test substance does not meet the classification criteria according to Regulation (EC) 1272/2008, and its data are therefore conclusive but not sufficient for classification.