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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 is from review article or handbook

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:
Skin irritation study of 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1) was conducted on intact and abraded skin of six New Zealand rabbits under semi-occlusive condition.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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
-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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Intact and abraded skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
500mg
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6
Details on study design:
SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.05
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No known signs of skin irritation were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1) was considered to be not irritating to the skin of New Zealand rabbits.
Executive summary:

Skin irritation study of 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1) was conducted on intact and abraded skin of six New Zealand rabbits under semi-occlusive condition.

 

About 500 mg of the4,4'-Methylenebis(2,6-di-tert-butylphenol)was applied for 24 hours under semiocclusive conditions. After 24 hours, the application site was scored at 24 or 72 hours according to Draize method.

 

No signs of irritation were observed and the observed irritation score was 0.5. Hence the chemical 4,4'-Methylenebis(2,6-di-tert-butylphenol)(CAS no: 118-82-1)was considered to be not irritating to the skin of New Zealand rabbits.