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Description of key information

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:
Study conducted from 17 April 1984 to 18 May 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(no individual test results given)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kingston, NY
- Age at study initiation: 5-6 weeks
- Weight at study initiation: Not stated
- Housing: maximum of 3 animals per cage
- Diet (e.g. ad libitum): Agway Charles River Guinea Pig Formula
- Water: tap water available ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 4
- Humidity (%): 50 ± 15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
10 % (intradermal and epicutaneous induction, challenge)
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10 % (intradermal and epicutaneous induction, challenge)
No. of animals per dose:
Pre-test group: 8
Test material Group: 15
Negative Control Group: 6
Details on study design:
RANGE FINDING TESTS:
Several animals were used to pretest the test material and vehicles to determine the dermal irritation threshold concentration. These animals were shaved on the left flank, to which was applied a 2 x 2 cm filter paper patch which contained 0.2 mL of the test concentration. The trunks of the animals are wrapped for 24 hours with a three inch wide elastic bandage to hold the patch in contact with the skin. Wrappings were removed after the 24 h exposure and, based on skin reactions at 48 h, a concentration of the test material to be used on main test is determined.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 hours
- Test groups: 15
- Control group: 6
- Site: shoulder region
- Frequency of applications: Three pairs of intradermal injections (Induction stage 1, intradermal induction) and once (induction stage 2, epicutaneous induction)
- Duration: 14 days (induction stage 1 and induction stage 2)
- Concentrations: 10 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 15
- Control group: 3 (The remaining three animals were reserved for possible rechallenge.)
- Site: shoulder flanks
- Concentrations: 10 %
- Evaluation (hr after challenge): 21 hours

OTHER:

a. If the first challenge is negative, then a second challenge will be performed one week later on the test group and three naive control animals.

b. The concentration (generally, between 1-5%) of test article in vehicle and in FCA that can be injected i.d. without eliciting a strong local or systemic toxic reaction will be used. This will be determined by preliminary experimentation.

c. For induction stage 2, a concentration of test article in vehicle will be determined prior to the study start date. The concentration will be the highest level that can be well tolerated locally and generally by the guinea pig, but yet is mildly irritating (if possible).

d. The highest concentration of test article in vehicle found to be nonirritating to the guinea pig skin by preliminary experimentation will be used for challenge application.

e. Pretest performed to determine concentrations for b.c and/or d. if necessary.
Challenge controls:
3 animals
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene
Positive control results:
100 %
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 6.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance was tested for skin sensitisation properties on guinea pigs using the maximisation test of Magnusson and Kligman (Walsh, 1984). A solution containing 10% test substance was used for intradermal and topical induction and for the challenge. After challenge, 2 of 15 animals of the test group showed skin reactions. No effects were observed in the negative control group. Dinitrochlorobenzene was used as positive control and revealed the expected reactions. Under the test conditions, the test substance was considered to not be skin sensitising.


Migrated from Short description of key information:
Skin sensitisation (GPMT): not sensitising (2 of 15 animals showed a positive reaction to the test substance in the Guinea pig maximisation test).

Justification for selection of skin sensitisation endpoint:
Only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Not required. No data available.


Migrated from Short description of key information:
Not required. No data available.

Justification for classification or non-classification

The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.