Ethyl 3,4-dihydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 April 2016 to 1 June 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2001

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 3,4-dihydroxybenzoate

EC Number:

223-529-0

EC Name:

Ethyl 3,4-dihydroxybenzoate

Cas Number:

3943-89-3

Molecular formula:

C9H10O4

IUPAC Name:

ethyl 3,4-dihydroxybenzoate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 160-203 g
- Fasting period before study: overnight until 3-4 hours after dosing
- Housing:3/cage (Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom))
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) ad libitum
- Water : tap water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40-70%
- Air changes (per hr): ≥10/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE: CMC

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

2000 mg/kg bw, 2000 mg/kg bw

No. of animals per sex per dose:

3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:mortality twice daily, clinical signs daily (3 times on day 1), body weight on day 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: yes first dose group: piloerection and hunched posture on day 1 second dose group: flat posture, hunched posture, piloerection, uncoordinated movements, quick breathing and/or ptosis on day 1

Gross pathology:

no abnormalities

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

based on the conclusion from the OECD test guideline, no classification according to CLP

Conclusions:

The LD50 of the substance is >2000 mg/kg bw. The substance does not need to be classified accoding to CLP

Executive summary:

The substance was administered by gavage to 3 female rats in an acute toxic class study. No mortality was found. Therefore 3 additional rats were treated at 2000 mg/kg bw. No mortality was observed. Body weight gain was within normal ranges. Clinical signs were reported on day 1 and consisted of flat posture, hunched posture, piloerection, uncoordinated movements, quick breathing and/or ptosis. Necropsy did not show any abnormalities. Therefore it is concluded that the LD50 of the substance is > 2000 mg/kg bw.