Salicylic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

study completed in 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted according to GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Reference 2

Reference Type:

publication

Title:

Acute toxicologic evaluation of salicylic acid

Author:

Bomhard E

Year:

1996

Bibliographic source:

J Am Coll Toxicol, Vol. 15, Suppl. 1, p. S81

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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:

- salicylic acid,
- purity: 99.8%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
Temperature, Humidity (%), Air changes (per hr), Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: cremophor EL

Details on dermal exposure:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data

Duration of exposure:

24 hours

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and gross pathological changes

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed

Clinical signs:

other: Poor general condition and piloerection: onset of symptoms was 1 h p.a.. On day 2 all animals were free of signs.

Gross pathology:

The gross examination revealed no significant findings.

Other findings:

- Other observations: No local effects  were observed. Two female rats presented a slight  increase in liver size.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Salicylic acid was not considered to be toxic by this route.

Executive summary:

In an acute dermal toxicity study (Bomhard, 1996), groups of Wistar rat (5/sex) were dermally exposed to Salicylic acid in cremophor EL ® for 24 hours at dose of 2000 mg/kg bw. Animals then were observed for 14 days. No death was observed. No local effects and no effect on the weight gain of the animals were noted. Dermal LD50 > 2000 mg/kg bw. Salicylic acid is not classified based on LD50 in both sexes.