5-(methoxymethyl)-2-furaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 26, 2010 - November 16, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

(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:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(2002)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-(methoxymethyl)furan-2-carbaldehyde

EC Number:

700-511-5

Cas Number:

1917-64-2

Molecular formula:

C7H8O3

IUPAC Name:

5-(methoxymethyl)furan-2-carbaldehyde

Details on test material:

- Name of test material (as cited in study report): MMF
- Description: Clear yellow liquid
- CAS Number: 1917-64-2

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:WI (Han) (outbred, SPF-Quality)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 165 - 196 g (body weight variation did not exceed +/- 20% of the sex mean)
- Fasting period before study: overnight prior to dosing until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water
- Acclimation period: at least 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 – 21.3
- Humidity (%): 43 - 71
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSE VOLUME APPLIED: 1.739 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable (limit test)

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 (2 subsequent groups of 3)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality/Viability: Twice daily
- Body weights: Days 1 (pre-administration), 8 and 15
- Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy.
- Other examinations performed: no

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: A combination of lethargy, hunched posture, uncoordinated movements, slow breathing, piloerection, watery discharge from the eyes, chromodacryorrhoea (snout) and/or ptosis was noted for all animals. The first set of animals had recovered from all symptoms

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In accordance with OECD guideline 423 (2001) and according to GLP principles the acute oral toxicity of the substance in rats was investigated. The oral LD50 value of MMF in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

In accordance with OECD guideline 423 (2001) and according to GLP principles the acute oral toxicity of the substance in rats was investigated. MMF was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. A combination of lethargy, hunched posture, uncoordinated movements, slow breathing, piloerection, watery discharge from the eyes, chromodacryorrhoea (snout) and/or ptosis was noted for all animals. The first set of animals had recovered from all symptoms on Day 5 and the second set of animals had recovered from all symptoms between Days 2 and 3. Two animals of the first set showed slight body weight loss or reduced body weight gain over the first week post-treatment. The mean body weight gain shown by the other animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of MMF in Wistar rats was established to exceed 2000 mg/kg body weight. Based on the results of this study, the substance does not need to be classified for acute oral toxicity in accordance with Regulation (EC) No 1272/2008.