Salicylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

data not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Few details are available, but the parameters are similar to OECD guideline. No information on test substance purity.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

IOnly male rats (strain not specified) were tested. No information on test substance purity. Insufficient detail on method in report to exclude other possible deviations.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Salicylic acid

EC Number:

200-712-3

EC Name:

Salicylic acid

Cas Number:

69-72-7

Molecular formula:

C7H6O3

IUPAC Name:

2-hydroxybenzoic acid

Details on test material:

- Name of test material (as cited in study report): Salicylic acid
- Substance type: pure active substance
- Physical state: solid
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: from 173g to 179g (mean body weight per group)
- Source, Age at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available

ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available

IN-LIFE DATES: data not available

Administration / exposure

Route of administration:

other: oral, probably gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): data not available
- Justification for choice of vehicle: data not available
- Lot/batch no.: data not available
- Purity: data not available

MAXIMUM DOSE VOLUME APPLIED: data not available

DOSAGE PREPARATION: data not available

Doses:

464, 681, 1000 and 1470 mg/kg

No. of animals per sex per dose:

5 male rats per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were weighted at study initiation (all groups) and termination (only the 464 mg/kg group).
They were observed for symptoms and mortality at 0-4h, 4-12h, 12-24h, and then after 2, 3, 4, 5, 6, 7 and 8-14 days
- Necropsy of survivors performed: yes

Statistics:

data not available

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

891 mg/kg bw

95% CL:

699 - 1 140

Mortality:

Mortality was observed at 681 mg/kg (1 animal), 1000 mg/kg (3 animals) and 1470 mg/kg (5 animals) (see Table 1)

Clinical signs:

other: Hypoactivity, muscular weakness

Gross pathology:

In survivors, no significant effects were observed.
In decedents, an inflammation of gastrointestinal tract was observed.

Any other information on results incl. tables

Table 1: Onset of symptoms and mortality

Dosage mg/kg	Conc. %	Onset of Symptoms (S) Mortality (M)										Cumulative Deaths	Body weight g		Time of recovery (Day)
		Hours			Days
		0-4	4-12	12-24	2	3	4	5	6	7	8-14		I	T
464	25											0 / 5	179	227
681	25		S	M (1)								1 / 5	176	-	Day 2
1000	25	S	M (1)	M (1)				M (1)				3 / 5	173	-	Day 5
1470	25	S	M (2)	M (2)		M (1)						5 / 5	175	-

S: onset of symptoms

M: onset of mortality (number of animals)

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The test substance is considered as harmful according to EU criteria and is classified in Category 4 according to the GHS (UN/EU)

Executive summary:

The acute oral toxicity of salicylic acid (purity unknown) was tested in a test similar to OECD guideline 401. Five male Albino rats per group (4 groups) were administrated a single dose of the test substance in a corn oil suspension. The dose were 464, 681, 1000 and 1470 mg/kg bw. The animals were then observed for 14 days.

Under the conditions of this test, the LD50 was 891 mg/kg bw. Signs of intoxication were hypoactivity and muscular weakness. At necropsy, no significant findings were observed in survivors, whereas inflammation of the gastrointestinal tract was observed in decedents. Based on the results of this study, salicylic acid would be classified as harmful in male rats by oral route, according to the Directive (67/548/EEC) on dangerous substance.