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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Justification for Read Across is explained in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6.0 cm × 5.0 cm (30.0 cm^2)
- Type of wrap if used: the test substance was transferred to a wet-gauze layer of a "Cutiplast steril®" and coated with air-tight "Leukoflex®". The gauze strip was placed on the rats back and secured in place using "Peha®-Haft" cohesive stretch tape and additionally covered with a "Lomir biomedical Inc rat jacket," connected with a safety pin to the stretch tape to ensure that animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing: dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry.
- Time after start of exposure: approximately 24 h.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred; the dose was tolerated by males and females.
Clinical signs:
No toxicologically relevant clinical signs.
Body weight:
No toxicological effects on weight development.
Gross pathology:
No findings.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

The acute dermal toxic potential of the test substance was examined according to the OECD guideline 402. Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semiocclusively for 24 hours. A dose of 2000 mg/kg body weight was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.

Conclusion

LD50 > 2000 mg/kg bw