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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study details are provided, preGLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Versatic 10
- Physical state: liquid
- Analytical purity: assumed 100%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory
- Age at study initiation: 12 weeks

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar skin
- % coverage:
- Type of wrap if used: bandaged into contact with the skin using an impermeable dressing of aluminum foil and waterproof plaster


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration (if solution): assumed 100%
Duration of exposure:
24 hours
Doses:
4 ml/kg (3640 mg/kg)
No. of animals per sex per dose:
2 rats per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: daily
Statistics:
LD50 was calculated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 640 mg/kg bw
Remarks on result:
other: No animals died
Mortality:
No animals died
Clinical signs:
No adverse effects noted
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for neodecanoic acid is greater than 3640 mg/kg.
Executive summary:

In this study male and female rats were exposed to 4 ml/kg (3640 mg/kg) neodecanoic acid via an occluded dermal patch for 24 hours. After 24 hours, the patch was removed and clinical observations were made once daily for 9 days. There were no deaths observed in this study and there were no signs of a toxicity response. It is concluded that the LD50 is greater than 3640 mg/kg.