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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 429(Skin Sensitization: Local Lymph Node Assay)
Principles of method if other than guideline:
A pre-test was performed to determine the highest non-irritant test chemical concentration for the main LLNA assay
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione
- Molecular formula : C16H8O2S2
- Molecular weight: 296.369 g/mol
- Smiles notation : O=C1c2c(S\C1=C1/Sc3c(cccc3)C1=O)cccc2
- InChl : 1S/C16H8O2S2/c17-13-9-5-1-3-7-11(9)19-15(13)16-14(18)10-6-2-4-8-12(10)20-16/h1-8H/b16-15-
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione
- Common Name: Thioindigo
- Molecular formula: C16H8O2S2
- Molecular weight: 296.369 g/mol
- Smiles notation: O=C1c2c(S\C1=C1/Sc3c(cccc3)C1=O)cccc2
- InChl : 1S/C16H8O2S2/c17-13-9-5-1-3-7-11(9)19-15(13)16-14(18)10-6-2-4-8-12(10)20-16/h1-8H/b16-15-
- Substance type: Organic
- Physical state: Solid
- Purity: >95%(w/w)
- Batch No.: AAFE 094505
- Stability: 0.1 mg/ml 4h in DMSO, 50 mg/ml 72h in DMSO
- Storage: At room temperature
- Expiration Date: October 21, 2015
- Manufacturing Date: October 21, 2005

Test animals

Species:
mouse
Strain:
other: CBA/CaOlaHsd
Details on test animals and environmental conditions:
Details on test animals and environmental conditions

Test Animals:

- Source: Harlan Netherlands
- Sex: Females
- Age: 6 - 12 weeks (beginning of acclimatization)
- Identification: Single caging. The animals will be distributed into the test groups at random and identified by cage number.
- Housing: single
- Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen) with granulated soft wood bedding (Harlan Winkelmann GmbH)
- Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH)
- Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf)
- Acclimatisation: Under test conditions after health examination. Only animals without any visible signs of illness will be used for the study.

Environmental Conditions:

- Temperature: 22 + 3°C
- Relative humidity: 30-79%
- Artificial light: 6.00 a.m. - 6.00 p.m.

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
other: DMSO
Controls:
not specified
Amount / concentration applied:
1.25, 2.5, 5 and 10% (w/v)
Duration of treatment / exposure:
single exposure
Observation period:
no data available
Number of animals:
2 females
Details on study design:
The ears were observed for local irritation or systemic toxicity

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The treatment of mice with 1.25, 2.5, 5 and 10% test item in DMSO did not show any signs of severe local irritation or systemic toxicity. Due to the discolouration by the test
item redness at the ears caused by irritation could not be observed.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The treatment of mice with 1.25, 2.5, 5 and 10% test item in DMSO did not show any signs of severe local irritation or systemic toxicity. Due to the discolouration by the test
item redness at the ears caused by irritation could not be observed.
Hence, the test chemical can be considered to be not irritating to the skin of mice.
Executive summary:

A pre-test was performed to determine the highest non-irritant test chemical concentration for the main LLNA assay.

1.25, 2.5, 5 and 10% (w/v) in DMSO were tested on one ear each of 2 female CBA/CaOlaHsd mice. The mice ears were observed for local irritation or systemic toxicity.

The treatment of mice with 1.25, 2.5, 5 and 10% test item in DMSO did not show any signs of severe local irritation or systemic toxicity. Due to the discolouration by the test

item redness at the ears caused by irritation could not be observed.

Hence, the test chemical can be considered to be not irritating to the skin of mice.