Registration Dossier

Administrative data

Description of key information

In a Maximisation test in guinea pigs performed in agreement with the protocol as described in OECD 406, a challenge with 30% of the test substance did not induce any skin reaction. It is concluded that the test substance does not induce sensitisation.

Justification for selection of skin sensitisation endpoint:
protocol in agreement with OECD 406

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:
11/04 1989 to 05/05 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study conform guidelines, non GLP, PIT not reported
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Adequateexisting data allow a conclusion on the sensitizing potential of the substance were available
Species:
guinea pig
Strain:
other: Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen
- Age at study initiation: young adults
- Weight at study initiation: 250-355 g
- Housing: 5 animals/macrolon IV cage
- Diet: G4 Ssniff standard laboratory guinea pig feed ad libitum
- Water: ad libitum
- Acclimation period: 1-5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 60±5 %
- Air changes (per hr):15/hr
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11-04-1989 To: 05-05-1989
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction : 10%
epicutaneous induction : 100%

epicutaneous challenge: 30%

all concentrations based on pre-tests to set irritant properties (not reported)
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Intradermal induction : 10%
epicutaneous induction : 100%

epicutaneous challenge: 30%

all concentrations based on pre-tests to set irritant properties (not reported)
No. of animals per dose:
19 in test group and 9 controls
Details on study design:
RANGE FINDING TESTS: performed but not reported; 100% indicated to give clear irritation (therefore no SDS used)

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal: 1 epicutaneous
- Duration: 48 hours epicutaneous
- Test groups: 19 animals
- Control group: 9 anaimals
- Site: 2X2 cm on flank
- Frequency of applications: intradermal on day 1 , epicutaneous on day 8
- Concentrations: 10% intradermal, 100% epicutaneous

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups: 19 animals
- Control group: 9 animals
- Site: 2X2 cm on flank
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hours

Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
severe body weight loss and paralysis after epicutaneous induction in all animals. Rrecovery after receiving additional vitamin C in drinking water.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: severe body weight loss and paralysis after epicutaneous induction in all animals. Rrecovery after receiving additional vitamin C in drinking water..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 19.0.
Interpretation of results:
other:
Conclusions:
The test substance did not induce sensitisation in guinea pigs in a maximisation test.
Executive summary:

In a Maximisation test in guinea pigs performed in agreement with the protocol as described in OECD 406, a challenge with 30% of the test substance did not induce any skin reaction. It is concluded that the test substance does not induce 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

The test substance does not need to be classified as skin sensitizer.