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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline. Rated as Klimisch 2 because it is a read-across study.

Data source

Reference
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:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Salicylic acid
EC Number:
200-712-3
EC Name:
Salicylic acid
Cas Number:
69-72-7
IUPAC Name:
salicylic acid
Test material form:
not specified
Details on test material:
Name: Salicylic acid
Purity: 99.8%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Acclimation period: 5 days
No further data.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: cremophor EL
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 hours

No further data.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
other: Poor general condition and piloerection: onset of symptoms was 1 hour post administration.. By day 2 all animals were free of signs.
Gross pathology:
No significant findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 for salicylic acid was > 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study, groups of Wistar rat (5 per sex) were exposed to salicylic acid in cremophor EL for 24 hours at dose of 2000 mg/kg bw. No deaths were observed. No local effects and no effect on the weight gain of the animals were noted. Therefore, the dermal LD50 is > 2000 mg/kg bw. Salicylic acid is not classified based this result.