2,2'-dihydroxy-4,4'-dimethoxybenzophenone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

HRIPT

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: HRIPT acc. Shelanski and Shelanski

Version / remarks:

Patch tests were conducted according to the method of Shelanski and Shelanski (Proceedings Of The Toilet Goods Association, Number 19, May, 1953).

Deviations:

not specified

Principles of method if other than guideline:

Patch tests were conducted on fifty human volunteers according to the method of Shelanski and Shelanski (Proceedings Of The Toilet Goods Association, Number 19, May, 1953).

GLP compliance:

no

Remarks:

conducted prior to GLP implementation

Type of study:

other: human repeated insult patch test

Justification for non-LLNA method:

Study was conducted prior to REACH implementation under a different regulatory context, and prior to the adoption of the respective guidelines.

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-dihydroxy-4,4'-dimethoxybenzophenone

EC Number:

205-027-3

EC Name:

2,2'-dihydroxy-4,4'-dimethoxybenzophenone

Cas Number:

131-54-4

Molecular formula:

C15H14O5

IUPAC Name:

2-(2-hydroxy-4-methoxybenzoyl)-5-methoxyphenol

Test material form:

solid

In vivo test system

Test animals

Species:

other: human

Strain:

other: not applicable

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

other: epicutaneous, patch test

Vehicle:

not specified

Challenge

Route:

other: epicutaneous, patch test

Vehicle:

not specified

No. of animals per dose:

50

Details on study design:

Patch tests were conducted on fifty human volunteers according to the method of Shelanski and Shelanski (Proceedings Of The Toilet Goods Association, Number 19, May, 1953).

Positive control substance(s):

not required

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Remarks on result:

no indication of skin sensitisation

Remarks:

The substance is neither a primary irritant nor a sensitizer. It is not a fatiguing agent.

Results 2

Group:

test chemical

No. with + reactions:

0

Total no. in group:

50

Remarks on result:

other: no more information given

Results 3

Group:

negative control

Remarks on result:

not measured/tested

Results 4

Group:

positive control

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the sensitizing potential of the registered substance in humans. The information is not given in a manner which allows classification according to Regulation 1272/2008 in its classic sense. However, the regulation allows to retrieve information on classification also from other sources. As none of the 50 human volunteers was stated to show reactions, it can be reasonably concluded that the substance would also not meet the classification criteria as set out in the regulation, so the substance can be considered non-sensitizing.

Executive summary:

Patch tests were conducted on fifty human volunteers according to the method of Shelanski and Shelanski (Proceedings Of The Toilet Goods Association, Number 19, May, 1953). The substance, when tested as supplied, is neither a primary irritant nor a sensitizer. It is not a fatiguing agent.