1H,3H-Naphtho[1,8-cd]pyran-6,7-dicarboxylic acid, 1,3-dioxo-

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: see 'Remark'

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: According to company guideline similar to OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dioxo-3-oxatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-8,10-dicarboxylic acid

EC Number:

619-817-4

Cas Number:

52671-72-4

Molecular formula:

C14H6O7

IUPAC Name:

2,4-dioxo-3-oxatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-8,10-dicarboxylic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Wistar, SPF-Albino
- Source: Hoechst, breeding colony
- Weight at study initiation: 202 g - 228 g, mean 219 g) on day 1 (treatment)
- Fasting period before study: approximately 16 hours before treatment
- Housing: plastic cages with softwood bedding
- Diet: Altromin 1324 ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % suspension

Doses:

2 500 mg/kg body weight
3 150 mg/kg body weight
4 000 mg/kg body weight
5 000 mg/kg body weight

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

None

Results and discussion

Preliminary study:

No differences between males and females were determined in preliminary tests. 250 mg/kg bw were administered to groups of 4 males and 4 females respectively, 1000 and 5000 mg/kg bw were administered to groups of 3 males and 3 females respectively. In the highest dose group one female died.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

3 508 mg/kg bw

Based on:

test mat.

Mortality:

Mortalities were observed at every dose level in the main study (see table below). Animals died within 2 to 6 days after administration of the test substance.

Clinical signs:

other: Crouched position, prone position, slightly increased respiration rate.

Gross pathology:

No abnormal macroscopic findings at scheduled necropsy in surviving animals and in animals found dead.

Other findings:

No other findigs

Any other information on results incl. tables

dose [mg/kg body weight]	number of animals	mortalities
2 500	10	4
3 150	10	6
4 000	10	5
5 000	10	9

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Single application of 2500, 3150, 4000 and 5000 mg per kg bw test item respectively did cause graduated lethality to female rats during the 14 days observation period. According to the method of Kärber the LD50 was calculated to be 3508 mg/kg bw.

Executive summary:

Female rats were subjected to test acute oral toxicity. The test item was administered at doses of 2500, 3150, 4000 and 5000 mg/kg bw to 10 female rats respectively. During the 14 days observation period animals died at any dose level. According to the method of Kärber the LD50 was calculated to be 3508 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.