Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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

Constituent 1
Reference substance name:
Diethylamino hydroxybenzoyl hexyl benzoate
IUPAC Name:
Diethylamino hydroxybenzoyl hexyl benzoate
Constituent 2
Chemical structure
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.