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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 26 November 1998 to 21 December 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid skin sensitisation test according to Magnusson & Kligman conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.

Test material

Constituent 1
Details on test material:
- Physical state:yellow clear liquid
- Stability under test conditions: no data on stability were available to LPT
- Storage condition of test material: at 20ºC to 30ºC

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 32 days
- Weight at study initiation: 238-303 g
- Housing: kept in pairs in MAKROLON cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3ºC
- Humidity (%): 60±20%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil DAB
Concentration / amount:
intracutaneous injection: 0.001, 0.01, 0.1, 1, 2 and 5%
topical application: 0.2, 2, 10, 20, 50 and 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil DAB
Concentration / amount:
intracutaneous injection: 0.001, 0.01, 0.1, 1, 2 and 5%
topical application: 0.2, 2, 10, 20, 50 and 100%
No. of animals per dose:
15 animals
Details on study design:
MAIN STUDY

Possible sensitising properties of the test compound were evaluated by administration of the test substance to the shoulder region, first by intracutaneous application (stage 1) and 7 days later by topical administration (stage 2, exposure time: 48 hours).
In a challenge test (stage 3) the test compound was again applied topically but to the flank region (exposure time: 24 hours). This area was then examined for reactions which might indicate sensitising properties to the test compound.

A. INDUCTION EXPOSURE
- Concentrations: Stage 1: Intracutaneous: 0.2%
Stage 2: topical: 10%
Stage 3: topical 0.01%

B. CHALLENGE EXPOSURE

- Day(s) of challenge: day 21
- Exposure period: 24 h
- Concentrations: 2 mL in left flank
2 ml in right flank

Erythema and eschar formation
no erythem: 0
slight erythema: 1
well-defined erythema: 2
moderate erythema: 3
severe erythema to slight eschar formation: 4
Maximum possible: 4

Oedema formation
no oedema: 0
slight oedema: 1
well-defined oedema: 2
moderate oedema: 3
severe oedema: 4
Maximum possible: 4
Positive control substance(s):
yes

Results and discussion

Positive control results:
Animals of this strain treated with potassium dichromate exhibited a sensitising reaction.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.01%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
The total number of animals in the negative group is not specified
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.01%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
The total number of animals in the negative control group is not specified
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
not applicable
Remarks on result:
positive indication of skin sensitisation
Remarks:
Number of animals in the positive control group as well as concentration of the reference susbtance not applicable

Any other information on results incl. tables

Concentration of Product (%) Route of Administration Animal no. Hours after start of treatment
24 h 48 h 72 h
5 intracutaneous 7 E3 E1 E1
2 7 E3 E1 E1
1 7 E1 E1 E1
0,1 8 E1 E1 0
0,01 8 0 0 0
0,001 8 0 0 0
non-depilated topical        
100 1 - E2 E3#
50 1 - E2 E2
20 2 - E1 E1
10 2 - E1 E1
2 3 - E1 0
0,2 3 - 0 0
depilated topical        
100 4 E1 E2 E3-4##
50 4 E1 E2 E3-4##
20 5 0 E2 E3
10 5 0 E2 E2
2 6 0 E1 E1
0,2 6 0 E1 E1
0,1 9 0 E1 E1
0,01 9 0 0 0
0,001 10 0 0 0
0,0001 10 0 0 0

#: laceration, necrosis

##: eschar formation, laceration, necrosis

E1: slight erythema

E2: well-defined erythema

E3: moderate to severe erythema

0: no pathological findings

-: not examined, 48 -h exposure/no values available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The product did not show any sensitising properties in guinea-pigs in a test model according to MAGNUSSON AND KLIGMAN.
Executive summary:

The purpose of this study was to determine the potencial of the product to provoke skin sensitisation reactions in guinea-pigs in a test model according to MAGNUSSON and KLIGMAN.

0.1 mL/animal (as a 0.2% concentration in sesame oil) chosen for the 1st (intracutaneous) induction stage and 2 ml/animal (as a 10% concentration in sesame oil) chosen for induction stage 2 (topical) produced a slight irritation in all animals. The challenge with 2 ml/animal (as a 0.01% concentration in sesame oil) revealed no sensitising properties.

The vehicle control animals treated with sesame oil in the same way during stages 1 and 2 and 2 ml of the product during the third stage also revealed no skin reactions.

Behaviour remained unchanged, body weight gain was within the normal range.

Under the present test conditions the product revealed no sensitising properties in guinea-pigs in a test according to MAGNUSSON and KLIGMAN.