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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Sept. 20, 1982 to Dec. 30, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Two intradermal and one epicutanous induction treatments; no sodium lauryl sulphate applied, no summary of the results of the reliability check provided.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Since valid in vivo data are available, no LLNA is necessary.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
EC Number:
253-039-2
EC Name:
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
Cas Number:
36443-68-2
Molecular formula:
C34H50O8
IUPAC Name:
ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pribright white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ivanovas Dermany
- Age at study initiation: 10 weeks old
- Weight at study initiation: 291 to 485 g
- Housing: individually in macrolon cages
- Diet: ad libitum standard guinea pig pellets NAFAG no. 830 supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 10 hrs dark/ 14 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
1%
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline PhH VI
Concentration / amount:
30%
Day(s)/duration:
48 h
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline PhH VI
Concentration / amount:
30%
Day(s)/duration:
24 h
No. of animals per dose:
10 male and 10 female per group
Details on study design:
RANGE FINDING TESTS:
The concentrations of the test compound for induction and challenge periods were determined on separate animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two (intradermal and epicutaneous)
- Test groups: three pairs of intradermal injections (0.1 ml per injection) into the neck of the guinea-pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later the test article was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals epicutaneously for 48 hours.
- Control group: treated with the vehicles alone
- Site: neck
- Concentrations: 1% for intradermal injection and 30% for epidermal application

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: 24 hours
- Test groups: Two weeks after the epidermal induction application the animals were tested on the flank with in vaseline
- Control group: treated with the vehicles alone
- Site: flank
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hours after removing the dressings the challenge reactions were graded according the Draize scoring scale
Challenge controls:
Vehicle only
Positive control substance(s):
no

Results and discussion

Positive control results:
The sensitivity of the strain is controlled every six months with p-phenylenediamine. No values given in the report.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 % (epicutaneous)
No. with + reactions:
0
Total no. in group:
19
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 % (epicutaneous)
No. with + reactions:
0
Total no. in group:
19
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% (epicutanous)
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% (epicutanous)
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

One animal died during the performance of the test. The death of the animal can not related to the compound application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No animal was sensitized by the test item under the experimental conditions employed and the test item can, therefore, be classified to the lowest sensitization grade according to Magnusson and Kligman (Appendix 2)
Executive summary:

In order to investigate the sensitization potential of the test item a maximization test according to Magnusson and Kligman was peformed using 10 male and 10 female guinea-pigs. Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea-pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours). Two weeks after the epidermal induction application the animals were tested on the flank with in vaseline (24 h occlusive application). Twenty-four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, 5 minutes) per group. A control group was treated with the vehicles alone (negative control). One animal died during the performance of the test. The death of the animal can not related to the compound application. No animal reacted after the challenge application and the test itel can therefore be classified to the lowest sensitization grade of Magnusson and Kligman.