5-Benzofuranacetic acid, 2,3-dihydro-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 05 February 2002 to 08 March 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study without detailed documentations. Clinical observations were limited to 1, 3, 5, 24 and 48 hours after administration of the test material.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

dated February 24th, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

dated December 29th, 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ADHBFA-Me

IUPAC Name:

ADHBFA-Me

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO (69210 L'Arbresle - France)
- Age at study initiation: no data
- Weight at study initiation: 166-189 g for males and 150-168 g for females
- Fasting period before study: no data
- Housing: no data
- Diet: Certified A04 Rats/Mice Maintenance Diet (document from supplier attached to the Study Report without further details)
- Water: no data
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-33
- Humidity (%): 33-49
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 1.7 ml/kg body weight

Doses:

2000 mg/ kg body weight

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: 1 hour, 3, 5, 24 and 48 hours after administration of the test material.
- Clinical observations: spontaneous activity, preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, turning reflex, back hair appearance
- Frequency of weighing: the day of administration of the test material (Day 0), and then at Days 2, 7 and 14.
- Necropsy of survivors performed: yes/ Observed organs: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thysmus, Trachea, Lungs, Heart, Kidneys, Urinary bladder, testis, ovaries, uterus, Adrenals and Pancreas
- Other examinations performed: clinical signs, body weight.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality and no clinical signs

Mortality:

No mortality occured during the study.

Clinical signs:

other: 3 hours after the administration of the test material, there was a decrease in the spontaneous activity in all the treated rats. Afterwards, rats recovered a normal activity, and 24 hours after the administration of the test material, no treatment related

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal any treatment-related change.

Other findings:

No further findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the oral LD50 of the test material is higher than 2000 mg/kg body weight without mortality or clinical signs. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.

Executive summary:

This GLP-compliant study was performed to assess the acute oral toxicity of the test material, according to OECD Guideline 401 (dated February 24th, 1987) and EU method B.1 of the E.E.C. directive n° 92/69 (dated December 29th, 1992).

 

Material and methods

The test material -diluted in distilled water- was administered by gavage to a group of 10 Sprague Dawley rats (5 males and 5 females) at a single dose of 2000 mg/kg body weight. A concurrent control group was treated in the same conditions with the vehicle alone.

Animals were monitored 1 hour, 3, 5, 24 and 48 hours after administration of the test material, and were weighed on days D0, D 2, 7 and 14.

 

Results

No mortality occurred during the study.

Three hours after the administration of the test material, there was a decrease in the spontaneous activity in all the treated rats. Then, rats recovered a normal activity, and 24 hours after the administration of the test material, no treatment related clinical signs were observed.

The body weight evolution of rats showed a decrease of the weight gain at Day 2 in the group of treated rats as compared to the control group (- 47% to male rats and - 86% to female's rats). Then, the weight evolution remained normal and at the end of the study, the weight was similar between treated and control animals.

The macroscopical examination of the animals at the end of the study did not reveal any treatment-related change.

 

Conclusion

Under the experimental conditions of this study, the oral LD50 of the test material is higher than 2000 mg/kg body weight without mortality or clinical signs. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.