1,2,3,6-tetrahydrophthalic anhydride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,6-tetrahydrophthalic anhydride

EC Number:

201-605-4

EC Name:

1,2,3,6-tetrahydrophthalic anhydride

Cas Number:

85-43-8

Molecular formula:

C8H8O3

IUPAC Name:

1,3,3a,4,7,7a-hexahydro-2-benzofuran-1,3-dione

Details on test material:

- Name of test material (as cited in study report):Tetrahydrophthalsäure-anhydrid (Tetra hydro phthalic acid anhydride)
- Physical state: solid
- Analytical purity: 98 %

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 233 +/-34.7 g (male); 203 +/- 38.7 (female)
- Fasting period before study: not reported, probably overnight before dosing
- Housing: groups
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous suspension of 1% Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2% ,16% and 20 % w/Vol.
- Justification for choice of vehicle: not given probably solubility

MAXIMUM DOSE VOLUME APPLIED: 6.9 mL

Doses:

200, 1600, 3200, 6400 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days (not supposed to have an influence on the result)
- Frequency of observations and weighing: only at study initiation for dose calculation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 200 mg/kg bw

Based on:

test mat.

Mortality:

200 mg/kg : 0/10
1600 mg/kg: 0/9
3200 mg/kg 5/10
6400 mg/kg 10/10

Clinical signs:

other: at toxic doses: Dyspnoea; abdominal position, staggering

Gross pathology:

animal sacrificed at study termination: nothing abnormal detected
animals that died: gastro intestinal irritation; corrosive effects

Applicant's summary and conclusion

Conclusions:

The LD50 following administration of a single oral dose to rats was approximately 3200 mg/kg body weight

Executive summary:

Acute oral toxicity has been investigated using methods similar to those described in OECD/EU test guidelines. The LD50 following administration of a single oral dose to rats was approximately 3200 mg/kg body weight