Biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-4-yl)-amine

Endpoint summary

Description of key information

Based on the data obtained from the structural analogue substance, the test item is not considered to be sensitizing to skin in the in vivo LLNA study according to OECD Guideline 429.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

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

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)

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

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

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.

Positive control results:

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

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%

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:

In the study the test item formulated in PG was assessed for its possible skin sensitising potential. For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w). 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.

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

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 429. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

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%

Interpretation of results:

GHS criteria not met

Conclusions:

For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 429. See chapter 13 report for a more detailed justification.
From this justification it can be concluded that there is no indication for skin sensitisation.

Reference 3

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the test item is not considered to be classified as skin sensitizer according to Regulation (EC) No 1272/2008.