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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:
19.09-21.10.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sample 838, B 255 A (03.06.1988)
- Purity test date: 14.07.1988

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 20°C
- Stability under test conditions: in the dark

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: HOECHST AG, Kastengrund, SPF-Zucht
- Strain: Hoe: DHPK(SPFLac)
- Weight at study initiation: x = 313g (=100 %); xmin= 286g (- 8,6%); * xmax= 337g (+ 7,7%); n = 15
- Housing: 5/ cage
- Diet: ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 2 % dermal induction: unchanged dermal challenge: 10 %
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 2 % dermal induction: unchanged dermal challenge: 10 %
No. of animals per dose:
pretest: 6 (determination of the non-irritating concentration determination of the intradermal tolerance: 3 control group 1: 5 control group 2: 5 treatment group: 10
Details on study design:
RANGE FINDING TESTS: (dermal occlusive on the flank skin): 100%, 10% and 1% in salineThe animal's fur was clipped and 0.5 mL of the test substance was applied on a patch that was fixed on the skin under occlusive condition for 24 hours. After 24 hours the patch was removed and the skin was assessed another 24 hours later for erythema and oedema reactions.To study the intradermal tolerance of the test substance, the substance was injected in concentrations of 0.2 %, 1 % and 5 % intradermally in the skin of the back, each concentration at two seperate areas.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal) and 1 epicutaneous- Exposure period: 48 hours (epicutaneous)
- Test groups: 2x 0.1 mL at a concentration of 2 % in 50% Freunds adjuvans; 2x 0.1 mL at a concentration of 2 % in NaCl 0.9 %; 2x 0.1 mL of 50% Freunds adjuvans (intradermal) 0.5 mL of the test substance or vehicle was applied on a 2 x 4 cm patch which was applied for 48 hours to the animal's skin under occlusive conditions
- Control group: 2x 0.1 mL of 50% Freunds adjuvans; 2x 0.1 mL NaCl 0.9 %; 2x 0.1 mL of 50% Freunds adjuvans (intradermal- Site: skin of the back
B. CHALLENGE EXPOSURE
- No. of exposures: 1- Test groups: 0.5 mL of the 10 % test substance or vehicle was applied on a 2 x 2 cm patch which was applied for 24 hours to the animal's skin under occlusive conditions
- Control group: 0.5 mL of the 10 % test substance in saline
- Site: flank skin- Evaluation (hr after challenge): 48 hours, 72 hours

OTHER: Time scale:
day 0: determination of body weight
day 1: intradermal induction
day 9: dermal induction
day 11: evaluation of skin irritation
day 22: dermal challenge
day 23: removal of occlusive dressing
day 24: 1st evaluation
day 25: 2nd evaluation

Scoring:equivalent to Draize scores
Challenge controls:
yes
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Body weight development:

mean body weight gain:

control group: 30.8 %

Treatment group: 35.7 %

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met