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Description of key information

Under the conditions of this study the test material was determined to be a very weak sensitiser.

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:
03 April 1985 to 17 May 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
The Magnusson and Kligman guinea pig maximisation test according to Test Method TM.002.03
The study was conducted in accordance with S.O.P.011/02
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study conducted prior to adoption of LLNA guideline by the OECD.
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 312 - 349 g
- Diet: RGP pellets, hay and cabbage
- Water: ad libitum

Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
0.25 %
Day(s)/duration:
1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Neat test material
Day(s)/duration:
6-7 days after the intradermal induction
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: acetone/PEG400
Concentration / amount:
25 %
Day(s)/duration:
12-14 days after epicutaneous induction. Patch was applied for 24 hours.
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: acetone/PEG400
Concentration / amount:
25 %
Day(s)/duration:
A second, third and fourth challenge were made at weekly or longer intervals as required and applied for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 animals in the test group and 4 treated control animals.
Details on study design:
TREATMENT
Sensitisation was induced in guinea pigs by intradermal injections of both test material and Freund's Complete Adjuvant and the induction process supplemented 6-7 days later by test material applied to the shoulder injection sites under occlusion. 12-14 days later the animals were challenged by occluded patch: further challenges were made at weekly or longer intervals as required.

- induction (intradermal injection): 0.25 %
- induction (covered patch application): neat
- challenge (covered patch application): 25 %

EVALUATION- SCORING SYSTEM
- Challenge patches were applied for 24 hours. Skin reaction sites examined 24 and 48 hours after removal of the patches, and scored according to the following:

Intradermal Injection:
fp = Faint pink
pp = Pale pink
p = Pink
dp = Deep pink
el = Elevation/oedema
n = Necrosis
w = White centre

Occluded Patch
0 = No reaction
0.5 = Very faint erythema (usually non-confluent)
1 = Faint erythema (usually confluent)
2 = Moderate erythema
3 = Marked erythema
Sp = Small spots of erythema
n = Necrosis
el = Elevation/oedema
w = White centres
Challenge controls:
Treated controls were used in the first and second challenges, untreated controls were used in the third and fourth challenges.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
Very faint erythema in one animal and faint erythema in one animal
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
Very faint erythema in four animals and faint erythema in one animal
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: treated control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: treated control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
3
Total no. in group:
9
Clinical observations:
Faint to moderate erythema in two animals and faint erythema in one animal
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
4
Total no. in group:
9
Clinical observations:
Moderate erythema in one animal, faint erythema in three animals and very faint erythema in one animal.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: treated control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: treated control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
other: challenge 3
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
Very faint erythema in five animals and faint erythema in one animal
Key result
Reading:
other: challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
Very faint erythema in four animals
Key result
Reading:
other: challenge 3
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
other: challenge 3
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
other: challenge 4
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
2
Total no. in group:
9
Clinical observations:
Very faint erythema in two animals, very faint to faint erythema in one animal, faint erythema in one animal and faint to moderate erythema with necrosis in one animal.
Key result
Reading:
other: challenge 4
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
Very faint erythema in two animals and faint to moderate erythema with necrosis in one animal.
Key result
Reading:
other: challenge 4
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
Very faint erythema in one animal..
Key result
Reading:
other: challenge 4
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
Very faint erythema in one animal..

- Evidence of sensitisation seen in one animal at challenge one was not confirmed at subsequent challenges. Two animals showed a positive response twice each out of challenges 2, 3 and 4.

- The test material is a very weak sensitiser by this method.

Interpretation of results:
other: Not classified in accordance with EU Criteria
Conclusions:
Under the conditions of this study the test material was determined to be a very weak sensitiser.
Executive summary:

The skin sensitisation potential of the test material was investigated with the Magnusson and Kligman guinea pig maximisation test according to Test Method TM.002.03.

Sensitisation was induced in guinea pigs by intradermal injections of both test material and Freund's Complete Adjuvant and the induction process supplemented 6-7 days later by test material applied to the shoulder injection sites under occlusion. 12-14 days later the animals were challenged by occluded patch: further challenges were made at weekly or longer intervals as required. The concentrations used in the test were: induction (intradermal injection): 0.25 %, induction (covered patch application): neat and challenge (covered patch application): 25 %.

Evidence of sensitisation seen in one animal at challenge one was not confirmed at subsequent challenges. Two animals showed a positive response twice each out of challenges 2, 3 and 4.

Under the conditions of this study the test material was determined to be a very weak sensitiser.

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

The skin sensitisation potential of the test material was investigated with the Magnusson and Kligman guinea pig maximisation test according to Test Method TM.002.03. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Sensitisation was induced in guinea pigs by intradermal injections of both test material and Freund's Complete Adjuvant and the induction process supplemented 6-7 days later by test material applied to the shoulder injection sites under occlusion. 12-14 days later the animals were challenged by occluded patch: further challenges were made at weekly or longer intervals as required. The concentrations used in the test were: induction (intradermal injection): 0.25 %, induction (covered patch application): neat and challenge (covered patch application): 25 %.

Evidence of sensitisation seen in one animal at challenge one was not confirmed at subsequent challenges. Two animals showed a positive response twice each out of challenges 2, 3 and 4.

Under the conditions of this study the test material was determined to be a very weak sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with skin sensitisation.