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Endpoint summary

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Description of key information

negative (mouse ear swelling test)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
MEST
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 Dec - 28 Dec 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Principles of method if other than guideline:
Method: according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114
GLP compliance:
not specified
Remarks:
Qualite Assurance Statement available
Type of study:
mouse ear swelling test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: C-1039

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Species:
mouse
Strain:
CF-1
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: River Breeding Laboratories, Inc. Kingston, New York
- Age at study initiation: Approximately 6-8 weeks
- Weight at study initiation: 20-26 grams
- Housing: housed 2-5/cage
- Diet: Purina Laboratory Chow, #5001, ad libitum
- Water (e.g. ad libitum): Municipal water supply, ad libitum
- Acclimation period: 13 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
1%
Adequacy of induction:
other: maximum non-corrosive concentration
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
50%
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
50%
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Range finding: 10
Sensitization Study: 20 test animals (10 per group)
Irritation Control: 15 (5 per group)
Positive control substance(s):
yes
Remarks:
DNCB (2,4-dinitrochlorobenzene)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
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:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
50%
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:
positive control
Dose level:
1%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. Conversely, 80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the test material exhibited no potential to produce sensitization in mice.
Executive summary:

The test substance was evaluated for dermal sensitization in 20 female CF-1 mice by mouse ear swelling test according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114. Following induction, the challenge was administered by topical application of 50% solution on day 10. A rechallenge was performed 7 days later with a topical application of 50% solution. Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. In contrast, 80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.

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

The test substance was evaluated for dermal sensitization in 20 female CF-1 mice by mouse ear swelling test according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114 (1987. Following induction, the challenge was administered by topical application of 50% solution on day 10. A rechallenge was performed 7 days later with a topical application of 50% solution. Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. In contrast, 80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 the substance is not classified for skin sensitization.