Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989
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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- salicylic acid,
- purity: 99.8%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed
Clinical signs:
Poor general condition and piloerection: onset of symptoms was 1 h p.a.. On day 2 all animals were free of signs.
Body weight:
No effect on the weight gain of the animals was noted.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.