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Administrative data

Description of key information

Skin: EU Method B.6, guinea pig. Not a sensitizer. Reliability = 1

Respiratory: No study available.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was performed prior to REACh guidance.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: not reported
- Weight at study initiation: 459-546 g
- Housing: suspended cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: Intradermal injection vehicle: 5% acetone; Topical application, both induction and challenge: acetone
Concentration / amount:
Intradermal injection: 0.5% w/w in 5% acetone in Alembicol D; topical induction: 80% w/w in acetone; topical challenge: 80% and 40% w/w in acetone

Route:
epicutaneous, semiocclusive
Vehicle:
other: Intradermal injection vehicle: 5% acetone; Topical application, both induction and challenge: acetone
Concentration / amount:
Intradermal injection: 0.5% w/w in 5% acetone in Alembicol D; topical induction: 80% w/w in acetone; topical challenge: 80% and 40% w/w in acetone

No. of animals per dose:
20 animals total were treated; both challenge doses were applied to the same animal
Details on study design:
RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify, where possible, irritant concentrations suitable for the induction phase of the main study and non-irritant concentrations by the topical route for the challenge phase. A concentration of 0.5% was chosen for the intradermal injection, as necrosis occurred at the injection site with all higher concentrations. There was no significant irritation at any concentration tested by the topical route. The maximum concentration chosen for topical application was 80% because this concentration of the test substance was the highest that could be prepared in acetone.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one exposure by intradermal injection and one by topical application
- Exposure period: one week after the injections, the topical dose was applied and left in place for 48 hours
- Test groups: one group of 20 animals
- Control group: one group of 10 animals
- Site: interscapular area
- Frequency of applications: once by injection and once topically to the same area
- Duration: topical application dressing was left in place for 48 hours
- Concentrations: 0.5% by intradermal injection; 80% by topical application

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: one
- Exposure period: 24 hours
- Test groups: one group of 20 animals were used. Each animal was challenged at two concentrations
- Control group: one group of 10 animals
- Site: area on the left flank
- Concentrations: 40% and 80%
- Evaluation (hr after challenge): 24, 48, and 72 hours after removal of the patches

Challenge controls:
The sensitivity of the guinea-pig strain used was checked periodically. The last check using the postive control substance was completed on February 10, 1990.
Positive control substance(s):
yes
Remarks:
formalin
Positive control results:
In the study completed on February 10, 1990, induction with 0.1% intradermal injection and 10% topical application followed by topical challenge with 5 and 1% formalin concentrations resulted in a positive result in 10/10 female guinea-pigs.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40% and 80%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40% and 80%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
40% and 80%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
other: overall evaluation
Group:
positive control
No. with + reactions:
134
Total no. in group:
149
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
In this screening test performed in twenty albino giunea-pigs, the test substance did not produce evidence of delayed contact hypersensitivity.
Executive summary:

The study was designed to assess the skin sensitixation potential of the test substance. Twenty female guinea-pigs were given induction doses by intradermal injection of 0.5%w/w in 5% acetone in Alembicol D and 0.5% w/w in a 50:50 mixture of Freund's complete adjuvant and 5% acetone in Alembicol D. Animals were also given an injection of Freund's complete adjuvant diluted with an equal volume of water into the same area at the same time. One week after the injections, the same area was clipped and shaved. A topical application of 80% w/w test substance in acetone was placed on the same area under a semiocclusive dressing and left for 48 hours. Two weeks later, the test animals were challenged topically using 80% and 40% concentrations of test substance in acetone. The patches were left in place for 24 hours. The challenge sites were evaluated 24, 48, and 72 hours after removal of the patches. A vehicle control group of 10 female guinea-pigs was given the same treatments with acetone vehicle. Reactions were scored on a scale from 0 to 4 for erythema, eschar formation and oedema formation. All test sites were scored 0 for both the test and control animals. The test substance did not produce evidence of delayed contact hypersensitivity.

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

The test substance did not produce skin sensitisation in laboratory animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance did not produce skin sensitization in laboratory animals. The substance does not need to be classified for skin sensitization according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.