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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study. Test item is a formulation with < 80% active ingredient.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(limit dose tested 2500 mg/kg bw, documentation limitations with respected to test animals and animal welfare)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Analytical purity: a solid formulation containing approx. 42% of the dye (100% pure)
Specific details on test material used for the study:
solid blend of the test substance with other ingredients.
Content of the test substance: 42%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Mean weight at study initiation: 145 g (male) and 131 g (female)
no further data available

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm²
- % coverage: at least 10% of body surface

TEST MATERIAL
- Amount(s) applied: 0.6 - 0.8 g/animal (5 mL / kg bw corresponds to 2.5 mg/kg bw)
- Concentration (if solution): 50%
- Paste formed: yes

REMOVAL OF TEST SUBSTANCE
- Washing: no
Duration of exposure:
24 h
Doses:
1050 mg/kg bw (a.i.)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: upon removal of test patch, then at least once daily
- Frequency of weighing: before treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Determination of the median lethal dose or LD50 calculated according to LITCHFIELD-WILCOXON

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 1 050 mg/kg bw
Based on:
other: formulation containing 42% of the test substance
Remarks on result:
other: 0 of 10 animals died
Mortality:
0/10
Clinical signs:
no abnormalities detected
Body weight:
body weight change was not determined
Gross pathology:
no abnormalities detected
Other findings:
Local irritation of skin: no
Upon removal of the test patches, light blue substance rests were present on the application site. This was no longer seen 4 days later.

Applicant's summary and conclusion