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Description of key information

Skin sensitisation. Key study (001). Test method according to 92/69/EWG, B.6 and OECD 406 Guidelines. GLP study.

Skin sensitisation. Key study (002). Test method according to 92/69/EWG, B.6. GLP study.

Data waiving (study scientifically not necessary / other information available): data from an in vivo study

was available. Therefore, an in vitro study was not deemed necessary.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.6
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Migrated from NONS file.
Species:
guinea pig
Strain:
Himalayan
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
20% test substance in 1% aqueous carboxylmethyl cellulose
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
5% test substance in 1% aqueous carboxylmethyl cellulose
No. of animals per dose:
Number of animals in test group: 10Number of animals in negative control group: 5
Challenge controls:
Negative challengue controls
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5

Maximum concentration not causing irritating effects in preliminary test: 20 %.

Signs of irritation during induction:

  • Erythema (24 h) and necrosis (24 and 48 h)after injection.
  • Erythema in 2 treated animals (day 10).

Evidence of sensitisation of each challenge concentration:

No evidence of sensitization.

Other observations:

None

Interpretation of results:
other: Not classified
Remarks:
Migrated information criteria used for interpretation of results: EU
Conclusions:
The test substance was not classified as a sensitisation agent.
Executive summary:

A skin sensitization test was performed according to OECD guideline 406 and 92/69/EWG, B.6 Guideline under GLP conditions.

 

Himalayan guinea pigs were administered with test substance using CMC as a vehicle (20% test substance in 1% aqueous CMC for test subjects and 5% test substance in 1% aqueous CMC for the challenge group). Readings were performed 24 and 48h after injection.

 

The results provided evidence that the test substance did not cause any irritating effects hence, the test substance is not classified as a skin sensitizer agent.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.6 (Meerschewinchen-Maximierungstest (GPMT))
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Migrated from NONS file.
Species:
guinea pig
Strain:
Himalayan
Route:
intradermal
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
0.2% test substance in 1% aqueous carboxylmethyl cellulose
Route:
other: Epidermal
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
20% test substance in 1% aqueous CMC
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
5% test substance in 1% aqueous carboxylmethyl cellulose
No. of animals per dose:
Number of animals in test group: 10Number of animals in negative control group: 5
Challenge controls:
Negative challengue controls
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5

Maximum concentration not causing irritating effects in preliminary test: 5 %.

Signs of irritation during induction:

  • Intradermal: 10/10 (Erythema 1/10, value 2); necrosis 9/10, diameter 2mm (7) or 3 (2) mm
  • Epidermal: 2/10 (Erythema, value 2)

Evidence of sensitisation of each challengue concentration: 0/10

Evidence of sensitisation of each challenge concentration:

No evidence of sensitization.

Other observations:

None

Interpretation of results:
other: Not classified
Remarks:
Migrated information criteria used for interpretation of results: EU
Conclusions:
The test substance was classified as a not sensitizing agent.
Executive summary:

A skin sensitization test was performed according to 92/69/EWG, B.6 Guideline under GLP conditions.

 

Himalayan guinea pigs were administered intradermally and epidermally with test substance, using CMC as a vehicle (0.2% test substance in 1% aqueous CMC for intradermal and 20% test substance in 1% aqueous CMC for epidermal). Readings were performed at 24 and 48h after injection.

 

The results provided evidence that the test substance can be classified as a non-sensitizer agent.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Justification for type of information:
A skin sensitisation in vivo was already available.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization. Key study (001). Test method according to 92/69/EWG, B.6 and OECD 406 Guidelines. GLP study. Himalayan guinea pigs were administered with test substance using CMC as a vehicle (20% test substance in 1% aqueous CMC for test subjects and 5% test substance in 1% aqueous CMC for the challenge group). Readings were performed 24 and 48h after injection. The results provided evidence that the test substance did not cause any irritating effects hence, the test substance is not classified as a skin sensitizer agent.

Skin sensitization. Key study (002). Test method according to 92/69/EWG, B.6., comparable to guideline but with acceptable restrictions. GLP study. Himalayan guinea pigs were administered intradermally and epidermally with test substance, using CMC as a vehicle (0.2% test substance in 1% aqueous CMC for intradermal and 20% test substance in 1% aqueous CMC for epidermal). Readings were performed 24 and 48h after injection. The results provided evidence that the test substance can be classified as a non-sensitizer agent.


Justification for selection of skin sensitisation endpoint:

No selection was done, both studies were negative.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on all the available information, test substance is not classified for skin sensitization.