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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was conducted in 1999, i.e. prior before REACH regulation came into force.

Test material

Constituent 1
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): Eldew PS-203
Physical state: pale yellow, oily liquid
Analytical purity: 100%
Purity test date: not reported
Lot/batch No.: 808010
Expiration date of the lot/batch: 31.03.2000
Storage condition of test material: test material was stored at room temperature (ca. 20°C), away from direct sunlight
Specific details on test material used for the study:
Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 358 - 415 g
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 38 - 64 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
1.) 0.1 mL of a 1:1 (v/v) mixture of FCA and physiological saline
2.) 0.1 mL of test item (5 %) in PEG 400
3.) 0.1 mL of test item (5 %) in a 1:1 (v/v) mixture of FCA and physiological saline
Day(s)/duration:
study day 1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Patch with 0.3 mL of undiluted test item
Day(s)/duration:
study day 8, duration 48 h
Challenge
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Patch with 0.2 mL of test item (10 % dilution)
Day(s)/duration:
study day 22, duration 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test group: 10 m
Control group: 5 m
Details on study design:
Maximum concentration causing no irritating effects in a preliminary test: 10%.
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A study with guinea pigs performed according to EU Method B.6 gave no indication for skin sensitisation.
Executive summary:

A study with guinea pigs performed according to EU Method B.6 gave no indication for skin sensitisation.