2,4-dihydroxybenzoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

females only tested;

GLP compliance:

no

Remarks:

pre-dates GLP regulations

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dihydroxybenzoic acid

EC Number:

201-946-9

EC Name:

2,4-dihydroxybenzoic acid

Cas Number:

89-86-1

Molecular formula:

C7H6O4

IUPAC Name:

2,4-dihydroxybenzoic 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: 86 g - 118 g, mean 99 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:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 % suspension

Doses:

1 600 mg/kg body weight
2 000 mg/kg body weight
2 500 mg/kg body weight
3 200 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:

Probit analysis

Results and discussion

Preliminary study:

No differences between males and females were determined in preliminary tests.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

3 327 mg/kg bw

Based on:

test mat.

Mortality:

Mortalities were observed at dose levels 2 500 to 5 000 mg/kg bw in the main study (see table below). Animals died within 1 hour to 3 days after administration of the test substance.

Clinical signs:

panting, disequilibrium, extensor spasms at prone position

Body weight:

Body weights of surviving animals were determined weekly during 14 days observation period.
The average increase of body weight at the end of the observation period was 5.4 % (low dose group) up to 10.4 % (high dose group)

Gross pathology:

macroscopic findings at necropsy in animals found dead: distinctly visible vessels in gastrointestinal tract

Other findings:

No other findigs

Any other information on results incl. tables

dose [mg/kg body weight]	number of animals	mortalities
1 600	10	0
2 000	10	0
2 500	10	3
3 200	10	4
4 000	10	6
5 000	10	10

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

the test item has not to be classified according to Regulation (EC) no 1272/2008

Conclusions:

Single application of 1 600, 2 000, 2 500, 3 200, 4 000 and 5 000 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 Linder and Weber the LD50 was calculated to be 3 327 mg/kg bw.

Executive summary:

Female rats were subjected to test acute oral toxicity. The test item was administered at doses of 1 600, 2 000, 2 500, 3 200, 4 000 and 5 000 mg/kg bw to 10 female rats respectively. During the 14 days observation period animals died at dose levels 2 500 and higher. According to the method of Linder and Weber the LD50 was calculated to be 3 327 mg/kg bw.

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