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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 18 - July 06, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-2-yl)-amine
EC Number:
700-681-0
Cas Number:
1364603-07-5
Molecular formula:
C52H37N
IUPAC Name:
Biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-2-yl)-amine
Test material form:
solid
Specific details on test material used for the study:
Batch: OS11008922
Appearance: Pale yellow powder without visible impurities
Expiry Date: 15 August 2016
Storage Conditions: At room temperature, protected from light and moisture
Purpose of Use: Industrial Chemical

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 9-10 weeks; Main test: 8 - 9 weeks
- Weight at study initiation: Pre-test: 20.5 g; Main test: 19.5+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
5, 10, and 25 (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 25% in PG
- Irritation: No
- Lymph node proliferation response: -

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Positive control results:
Conc. SI
0%: 1.00
5% 1.93
10% 2.65
25% 9.48

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
Test Group: 5%
Key result
Parameter:
SI
Value:
1.06
Test group / Remarks:
Test Group: 10%
Key result
Parameter:
SI
Value:
1.14
Test group / Remarks:
Test Group: 25%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not a skin sensitiser under the test conditions of this study.
Executive summary:

Objective


In the study the test item formulated in PG was assessed for its possible skin sensitising potential.


 


Study Design


For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w).


 


Results


The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.


In this study Stimulation Indices (S.I.) of 1.60, 1.06, and 1.14 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in PG, respectively.


 


Conclusion


The test item was not a skin sensitiser under the test conditions of this study.