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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Limited study summary, no GLP, deviations compared to OECD 402

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid
EC Number:
200-618-2
EC Name:
Benzoic acid
Cas Number:
65-85-0
Molecular formula:
C7H6O2
IUPAC Name:
Benzoic acid
Test material form:
not specified
Details on test material:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2311 - 2812 grams
- Diet (ad libitum)
- Water (ad libitum)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the back
- Type of wrap if used: gauze bandages and Saran Wrap


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): undiluted
- For solids, paste formed: no


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male and 2 female per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Other examinations performed: body weight,organ weights
Statistics:
None stated

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No information provided
Body weight:
Normal body weight gains was observed.
Gross pathology:
No information provided

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the dermal route.
Executive summary:

4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.

The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.