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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:
11 Jun - 02 Aug 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
: no positive control data mentioned in study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
no positive control mentioned in study report
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
not specified
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted in 1996, prior to adoption of LLNA method in 2002.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HARLAN WINKELMANN, Borchen, Germany
- Microbiological status of animals, when known: SPF breeding colony
- Weight at study initiation: 361 - 453 g
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: Commercial diet, (ssniff Ms-H(V2233), ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 11 Jun - 17 Jul 1996

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
On each of days 1, 8, and 15 for 6-hour exposure duration
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
On day 29, 6-hour exposure
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 negative control
20 test animals
Details on study design:
RANGE FINDING TESTS:
Six animals were used for determination of non-irritant concentration: 4%, 20% and 100% in deionized water was applied topically to two guinea pigs per concentration. The hair on the left flank of the animals was removed mechanically. An amount of 0.5 mL of the test substance was applied to a 2 x 2 cm cellulose patch, which was fixed to the left flank and covered occlusively for 6 hours with a bandage and film. After 24 hours following removal of the patches, the treated skin areas were examined for erythema and oedema, and skin reactions were assessed according to Draize scoring system.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: During Day 1-15 topical exposure was done once a week.
- Test groups: 20 animals
- Control group: 10 animals
- Site: Left flank: 0.5 mL of the test substance was applied over a 2 x 2 cm patch. Control animals were treated with analogously with water.
- Frequency of applications: once a week
- Duration: 6 hour exposure under occlusive bandage
- Concentrations: 100%
After induction exposure the occlusive bandage was removed and the skin washed. Clinical signs and irritant effects were recorded.

B. CHALLENGE EXPOSURE
The hair of the previously untreated right flank was removed mechanically.
- No. of exposures: 1
- Day(s) of challenge: Day 29
- Exposure period: 6 hour exposure under occlusive bandage
- Test groups: 20 animals
- Control group: 10 animals
- Site: Right flank: 0.5 mL of the test substance was applied over a patch.
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches.
After removal of the occlusive bandage, any remnants of the substance were carefully washed off with warm water.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No information on positive control data available from study report.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none, no erythema, no oedema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none, no erythema, no oedema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none, no erythema, no oedema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none, no erythema, no oedema
Group:
positive control
Remarks on result:
other: no information on positive control mentioned in study report.

Any other information on results incl. tables

Range finding test: As no signs of irritation occurred after application of the different test concentrations, 100 % was selected for challenge application.

The body weight gains of the animals were not impaired.

The animals of the treatment and control group showed no signs of irritation during induction phase.

No signs of irritation (no erythema and no oedema) were observed in the control and the treatment group 24 and 48 hours after removal of challenge patches.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.