Cyclohexane-1,2-dicarboxylic 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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Four groups, each of 5 male and 5 female rats, administered a single oral dose, by gavage. Animals assessed for 7 days after which survivors were killed and subjected to necropsy examination.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexane-1,2-dicarboxylic anhydride

EC Number:

201-604-9

EC Name:

Cyclohexane-1,2-dicarboxylic anhydride

Cas Number:

85-42-7

Molecular formula:

C8H10O3

IUPAC Name:

octahydro-2-benzofuran-1,3-dione

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zucht Winkelmann, Paderborn, Germany
- Weight at study initiation: 120 - 145 g
- Fasting period before study: Yes - 16 hours
- Diet (e.g. ad libitum): Rodent diet, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deg C
- Humidity (%): 45 - 55%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 12.5 - 24.8 mL/kg body weight
- Justification for choice of vehicle: Substance unstable in aqueous media

MAXIMUM DOSE VOLUME APPLIED: 24.8 mL/kg body weight

Doses:

2520, 3180, 3980 and 5000 mg/kg

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Examination 2, 24 and 48 hours post-dose and again after 7 days. Weighing on day of dosing and again after 7 days
- Necropsy of survivors performed: Yes

Statistics:

Litchfield and Wilcoxon

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 040 mg/kg bw

Based on:

test mat.

95% CL:

3 580 - 4 570

Mortality:

Dose level [mg/kg] - 2520; Males 0% Females 0%
- 3180: Males 20% Females 20%
- 3980: Males 40% Females 40%
- 5000: Males 100% Females 100%

Clinical signs:

other: Reduced activity, piloerection and ataxia observed following dosing and for at least 24 hours.

Gross pathology:

No notable findings in surviving animals

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute oral toxicity (LD50) of hexahydrophthalic anhydride is 4040 mg/kg body weight

Executive summary:

Acute oral toxicity following administration of a single dose has been investigated in the rat according to FHSA test methods. The median lethal dose (LD50) of hexahydrophthalic anhydride was determined to be 4040 mg/kg body weight.