Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

secondary source

Title:

Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester-COLIPA n° S83

Author:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP)

Year:

2006

Bibliographic source:

Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester-COLIPA n° S83- SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP)- 20 June 2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

The skin sensitization test of Diethylamino hydroxybenzoyl hexyl benzoate) was conducted in 10 female guinea pigs to determine its sensitization potential.

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:

Diethylamino hydroxybenzoyl hexyl benzoate

IUPAC Name:

Diethylamino hydroxybenzoyl hexyl benzoate

Constituent 2

Reference substance name:

Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester

Cas Number:

302776-68-7

Molecular formula:

C6H5NO2

IUPAC Name:

Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester

Constituent 3

Reference substance name:

-

EC Number:

443-860-6

EC Name:

-

IUPAC Name:

443-860-6

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester
- Molecular formula : C24H31NO4
- Molecular weight : 397.5119 g/mol
- Substance type: Organic
- Physical state: Solid (powder)
- Purity: 99.35%
- Impurities (identity and concentrations): 00.65%

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

female

Details on test animals and environmental conditions:

- Age at study initiation: 327 – 375 g

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

olive oil

Concentration / amount:

INTRADERMAL INDUCTION: Test substance 5% in olive oil or 5% in Freund's adjuvant, 10.9% aqueous NaCl-solution (1:1)

EPICUTANEOUS INDUCTION: Test substance 25 % in olive oil

Day(s)/duration:

24 hours, 6 exposures

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

olive oil

Concentration / amount:

CHALLENGE: Test substance 25 % in olive oil

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No. of animals per dose:

20 Guinea pigs
10: Test group
10: Control group

Details on study design:

MAIN STUDY
A. 1.INDUCTION EXPOSURE
- No. of exposures:6
- Exposure period:24 hours
- Test groups:10 Guinea pigs
- Control group: Guinea pigs
- Site: no data available
- Frequency of applications:
- Duration:24 hours
- Concentrations: Test substance 5% in olive oil or 5% in Freund's adjuvant, 10.9% aqueous NaCl-solution (1:1)

A.2. EPICUTANEOUS INDUCTION EXPOSURE
- No. of exposures:1
- Exposure period:48 hours
- Test groups: 10 Guinea pigs
- Control group: 10 Guinea pigs
- Site: no data available
- Frequency of applications:
- Duration:48 hours
- Concentrations: Test substance 25 % in olive oil


B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 14 days after the
epicutaneous induction
- Exposure period: 24 hours
- Test groups: 10 Guinea pigs
- Control group: 10 Guinea pigs
- Site:no data available
- Concentrations: Test substance 25 % in olive oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches.

Challenge controls:

No data available

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

25 % in olive oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

moderate and confluent erythema and swelling or intense erythema, Incrustation and oedema

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 % in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: moderate and confluent erythema and swelling or intense erythema, Incrustation and oedema.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

No skin reactions could be observed neither in control group nor in the test group, 24 and 48 hours after removal of the patches. Olive oil, which was applied as a vehicle control to all animals, did not cause any skin reactions. Since no borderline results were observed, a 2nd challenge was not performed.
 
Therefore, it was concluded that the test substance Diethyl amino hydroxybenzoyl hexyl benzoate(CAS No: -302776-68-7)does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.

Executive summary:

The skin sanitization test of Diethylamino hydroxybenzoyl hexyl benzoate(CAS No: -302776-68-7)was conducted in 10 female guinea pigs to determine its sensitization potential. The study was conducted according to OECD 406 Guidelines.

 

For intradermal induction, the test animals received 6 injections (2 injections of a 0.1 ml Freund’s adjuvant/aqua dest 1:1, 2 injections of 0.1 ml of a 5% test substance formulation, 2 injections of a 0.1 ml 5% test substance formulation in Freund’s adjuvant/aqua dest 1:1). The intradermal induction with 5% test substance preparations caused moderate and confluent erythema and swelling or intense erythema and swelling in test group animals at 24 h after application. Percutaneous induction was carried out 1 week after intradermal induction. The test substance (25% in olive oil) and the vehicle were applied for 48 h to the animals under occlusive conditions. Incrustation, erythema and oedema were observed in test and control animals at 48 h after beginning of application. After the epicutaneous induction, incrustation, partially open (caused by the intradermal induction) could be observed in addition to moderate and confluent erythema and swelling in all test groups animals. A challenge with a 25% test substance preparation in olive oil was performed 14 days after the epicutaneous induction. No skin reactions could be observed neither in control group nor in the test group, 24 and 48 hours after removal of the patches. Olive oil, which was applied as a vehicle control to all animals, did not cause any skin reactions. Since no borderline results were observed, a 2nd challenge was not performed.

 

Therefore, it was concluded that the test substance Diethyl amino hydroxybenzoyl hexyl benzoate(CAS No: -302776-68-7)does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.