1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

4,4'-methylenebis (2,6-di-tert-butylphenol) [MAK Value Documentation in German language, 2014].

Author:

The MAK Collection for Occupational Health and Safety.

Year:

2014

Bibliographic source:

4,4'-methylenebis (2,6-di-tert-butylphenol) [MAK Value Documentation in German language, 2014]. The MAK Collection for Occupational Health and Safety. 1-24. 2014.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The maximization test of Magnusson and Kligman to ten male and female Dunkin-Hartley guinea pigs for chemical 4,4'-Methylenebis(2,6-di-tert-butylphenol) (CAS no: 118-82-1) to examine the efficacy of contact sensitization.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2',6,6'-Tetra-tert-butyl-4,4'-methylenediphenol

Cas Number:

118-82-1

Molecular formula:

C29H44O2

IUPAC Name:

2,2',6,6'-Tetra-tert-butyl-4,4'-methylenediphenol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): 4,4'-Methylenebis(2,6-di-tert-butylphenol)
- Molecular formula: C29H44O2
- Molecular weight: 424.665 g/mol
- Substance type: organic
- Physical state: solid
- InChI: 1S/C29H44O2/c1-26(2,3)20-14-18(15-21(24(20)30)27(4,5)6)13-19-16-22(28(7,8)9)25(31)23(17-19)29(10,11)12/h14-17,30-31H,13H2,1-12H3
-Smiles: C(c1c(c(C(C)(C)C)cc(c1)Cc1cc(C(C)(C)C)c(O)c(c1)C(C)(C)C)O)(C)(C)C

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4,4'-Methylenebis(2,6-di-tert-butylphenol)
- Molecular formula: C29H44O2
- Molecular weight: 424.665 g/mol
- Substance type: organic
- Physical state: solid
- InChI: 1S/C29H44O2/c1-26(2,3)20-14-18(15-21(24(20)30)27(4,5)6)13-19-16-22(28(7,8)9)25(31)23(17-19)29(10,11)12/h14-17,30-31H,13H2,1-12H3

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: vaseline.

Concentration / amount:

Intradermal Induction: 0.5% of 4,4'-methylenebis (2,6-di-tert-butylphenol), and Freund's adjuvant.
Dermal Induction: 50% in Vaseline.

Day(s)/duration:

Intradermal Induction: 1 week ; Dermal Induction: no data

Adequacy of induction:

not specified

Challenge

Route:

epicutaneous, occlusive

Vehicle:

other: Vaseline.

Concentration / amount:

50%

Day(s)/duration:

72 hours

Adequacy of challenge:

not specified

No. of animals per dose:

10

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week
- Test groups: 10
- Control group: no data
- Site: no data
- Frequency of applications: 1 intradermal and 1 dermal application
- Duration: no data
- Concentrations: Intradermal Induction : 0.5% of 4,4'-methylenebis (2,6-di-tert-butylphenol), and Freund's adjuvant,

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 weeks
- Exposure period: 24 hours
- Test groups:10
- Control group: no data
- Site: no data
- Concentrations: 50%
- Evaluation (hr after challenge): at 24, 48 or 72 hours

Challenge controls:

not specified

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

50%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No skin sensitizing effects were observed in treated guinea pigs at 24, 48 or 72 hours.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

No skin sensitizing effects were observed in treated guinea pigs at 24, 48 or 72 hours.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1) was considered to be not sensitizing in a maximization test of Magnusson and Kligman conducted on ten male and female Dunkin-Hartley guinea pigs.

Executive summary:

The maximization test of Magnusson and Kligman to ten male and female Dunkin-Hartley guinea pigs for chemical 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1) to examine the efficacy of contact sensitization.

 

Intradermal Induction was carried out with 0.5% of 4,4'-methylenebis (2,6-di-tert-butylphenol), and Freund's adjuvant and the epidermal induction was performed one week later at 50% of 4 , 4'-methylenebis (2,6-di-tert-butylphenol) in vaseline.

 

After the non treatment period of 2 weeks, animals were challenged at the same concentration used during epidermal induction (50% in vaseline).

 

None of the treated guinea pigs showed positive response at 24, 48 or 72 hours. Therefore the chemical 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1)was considered to be not sensitizing onDunkin-Hartley guineapigs’ skin.