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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989-10-31 to 1989-12-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP study, please refer to section 13 for read across justification

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:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In 1992 (performance of the available study), the LLNA was not a standard test method.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann, Borchen/D
- Weight at study initiation: 380-390 g, 350-390 g
- Housing: Makrolon cages IV
- Diet: 3032 DK (Altromin GmbH, Lage/D), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C
- Humidity (%): 45-70%
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Vaseline and NaCl
Concentration / amount:
Pretest: 0.5, 1, 2, 3 %
Main test: Intracutaneous Induction: 0.3 % in NaCl
Epicutaneous Induction: 60 % in Vaseline
Challenge: 40 % in Vaseline and 40 % NaCl
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline and NaCl
Concentration / amount:
Pretest: 0.5, 1, 2, 3 %
Main test: Intracutaneous Induction: 0.3 % in NaCl
Epicutaneous Induction: 60 % in Vaseline
Challenge: 40 % in Vaseline and 40 % NaCl
No. of animals per dose:
36 animals in total
(2x3 in the preliminary test, 20 animals in testing group, 10 animals in control group)
Details on study design:
RANGE FINDING TESTS: The minimal irritating doses were determined on 3 guinea-pigs. All animals were applied 0.1 mL 50 % Freundsche Adjuvans before the preliminary tests.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intracutaneous and epicutaneous), the epicutaneous injection was done 8 days after the first injection
- Exposure period: 48 hours
- Test groups:
Intracutaneous Application: 20 animals received 0.1 mL of the following solutions: 1. Freudsche Adjuvans, 2. the minimal concentration of the test substance, 3. the test substance in combination with the Freundsche Adjuvans
Epidcutaneous: 20 animals received 0.5 g of the minimal irritating concentration (60 % in vaseline)-

- Control group:
Intracutaneous application: 10 animals received the Freudsche Adjuvans but not the test substance.
Epicutaneous application: 10 animals received 0.5 g of the vehicle.
- Site: to the clipped site (shoulder-back region) of the animals (intracutaneous), to the again clipped same site as during the intracutaneous induction (epicutaneous)
- Concentrations: 0.3 % in NaCl (intracutaneous), 60 % in Vaseline (epicutaneous)
- Evaluation: After 1 and 24 hours (intracutaneous and epicutaneous)

B. CHALLENGE EXPOSURE
- No. of exposures: 2 (1st: 40 % in Vaseline, 2nd: 40 % in NaCl)
- Exposure period: 24 hours
- Observations: After 24 and 48 hours
- Test groups: 20 animals: The animals got the 0.1 mL of the 40 % test substance in vaseline.
- Control group: 10 animals: Also the control group got 0.1 mL of the 40 % test substance in vaseline.
- Site: To another clipped site of the animals
- Concentrations: 0.1 mL of the 40 % solution with Vaseline
- Evaluation (hr after challenge): 24, 48 hours

Challenge controls:
Two challenge controls were conducted, one with 40 % in Vaseline and one with 40 % in NaCl

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40 % in Vaseline
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
Not relevant for evaluation due to irritating properties of the vehicle
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 % in Vaseline. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
40 % Vaseline
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
Not relevant for evaluation due to irritating properties of the vehicle
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 % Vaseline. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
40 % in NaCl
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Because of irritating effects due to Vaseline a 2nd reading was done
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 % in NaCl. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Because of irritating effects due to Vaseline a 2nd reading was done.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
40 % in NaCl
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Because of irritating effects due to Vaseline a 2nd reading was done
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 % in NaCl. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Because of irritating effects due to Vaseline a 2nd reading was done.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 % in Vaseline
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
Not relevant for evaluation due to irritating properties of the vehicle
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 % in Vaseline. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
40 % in Vaseline
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
Not relevant for evaluation due to irritating properties of the vehicle
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 % in Vaseline . No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 % in NaCl
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 % in NaCl. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40 % in NaCl
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 % in NaCl. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion