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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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Year 1981
Deviations:
yes
Remarks:
results of reliability checks not reported in study report
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright Bor: DHPW (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht Gartenstrabe 30, Animal Virus Research Institut, Pirbright Woking Surrey
- Weight at study initiation: 229 - 340 g
- Housing: Maximum 5 animals per cage
- Diet (e.g. ad libitum): ad libitum, Ssniff-G (pellets, 1.0cm large, 0.5 cm diameter), Ssniff Spezialdiaten GmbH
- Water (e.g. ad libitum): ad libitum, aqua fontana as for human consumption
- Acclimation period: Not less than 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2 °C
- Humidity (%): 50-85%
- Photoperiod (hrs dark / hrs light): 12/12


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Oleum arachidis
Concentration / amount:
For intradermal injections the concentration of the test substance (TS) was 10% in the vehicle and 10% in Freund's Adjuvant complete (FCA)
For the Dermal treatments the test material was 75% in the vehicle
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Oleum arachidis
Concentration / amount:
For intradermal injections the concentration of the test substance (TS) was 10% in the vehicle and 10% in Freund's Adjuvant complete (FCA)
For the Dermal treatments the test material was 75% in the vehicle
No. of animals per dose:
20 test animals and 20 control animals
Details on study design:
RANGE FINDING TESTS:
To exclude primary skin irritations two animals/group were treated once dermally in a preliminary study under occlusive conditions with the following concentrations (each 0.5 mL/animal) of the sample: 100% (undiluted), 75%, 50%, and 10% in Oleum arachidis; intradermal: 10% and 5% in Oleum arachidis.
The range finding study found slight erythema at 100% (undiluted) concentrations of the test substance, therefore, for the purposes of the sensitization study the concentration of 75% , which produced only slight erthyema, was used.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal then epicutaneous)
- Exposure period: 48 hours (epicutaneous)
- Test groups: 1st induction (0.05 mL): TS (10%) + Oleum arachidis; TS (10%) + FCA; FCA (undiluted). 2nd induction (0.5 mL): TS (75%) in Oleum arachidis
- Control group: 1st induction (0.05 mL): FCA (undiluted); FCA + Oleum arachidis (10%); Oleum arachidis (undiluated); . 2nd induction (0.5 mL): Oleum arachidis (undiluted)
- Site: back (skin areas situated bilaterally to the spin)
- Duration: 3 weeks
- Concentrations: same as mentioned above throughout the study


B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: 0.5 mL of TS (75%) in Oleum arachidis
- Control group: 0.5 mL of Oleum arachidis (undiluted)
- Site: Left clipped flank (Test group); Right clipped flank (control group)
- Concentrations: 75% TS
- Evaluation (hr after challenge): 24 and 48 h after removal of TS


Challenge controls:
The control group served to demonstrate that results observed were not attributable to the vehicle used.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None reported.
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control
Dose level:
Vehicle only
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Vehicle control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group:

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified