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Diss Factsheets

Administrative data

Description of key information

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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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 %
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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

Therefore, there is no need to classify the test item according to CLP.