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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:
No test material purity is stated in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only limited information on test procedure and test material identity are given, and no test material purity is stated in the study report, only 2 dose levels tested with 4 animals/dose group
GLP compliance:
no
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): Silicone A-164
- Physical state: light yellow liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Diet: ad libitum (not further specified)
- Water: ad libitum (not further specified)

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The trunk of the animals was exposed to the test material.
- Type of wrap if used: polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing: Excess of the test material is removed after the exposure period to prevent ingestion.
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
8.0 and 16 mL/kg bw
No. of animals per sex per dose:
4 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
16 mL/kg bw
Based on:
test mat.
95% CL:
4.48 - 57.2
Remarks on result:
other: equivalent to: LD50 = 13840 mg/kg bw
Mortality:
No mortality occurred at a dose level of 8.0 mL/kg bw (0/4), whereas 2/4 animals died during the study period when administered the test material at a dose level of 16.0 mL/kg bw.
Clinical signs:
No clinical signs of toxicity were recorded during the study period.
Body weight:
Mean body weight changes seen throughout the study period were:
8.0 mL/kg bw: -457 to +126 g
16.0 mL/kg bw: +159 to +196 g
Gross pathology:
Gross pathology of dead animals revealed red/pink or orange mottled livers, purple spleens and red kidneys. No abnormalities were found in surviving animals.
Other findings:
Neither erythema nor edema were recorded in 5/8 animals during the study period. 3/8 animals showed erythema and edema formation (grade 1) as well as ecchymosis and scabs after the 14-day study period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Conclusions:
In summary, the acute dermal LD50 value for male rabbits was considered to be 16 mL/kg bw (corresponding to 13840 mg/kg bw). Therefore, the test substance does not need to be classified for acute dermal toxicity according to Regulation (EC) No 1272/2008.