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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no data on positive control/strain sensitivity

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)
Version / remarks:
adopted in May 1981
Deviations:
yes
Remarks:
(no data on positive control/strain sensitivity)
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted.
This test is considered appropriate and it is not justified to conduct an additional LLNA study due to animal welfare.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino guinea pig, Bor:DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 359.1 g (test group), 378.9 g (control group)
- Housing: 1-5 animals/cage in Makrolon cages type IV
- Diet: G4 Alleindiaet fuer Meerschweinchen (Ssniff Spezialfutter GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 Mar 1988 To: 25 Mar 1988

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 5% in vehicle
epicutaneous induction: 100%
epicutaneous challenge: 100%

Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 5% in vehicle
epicutaneous induction: 100%
epicutaneous challenge: 100%

No. of animals per dose:
test group: 20
control group: 10
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

- Test groups:
Intradermal (3 pairs of injections (0.1 mL)):
Injection 1: a 1:1 mixture Freunds complete adjuvant (FCA)/water
Injection 2: 5% test substance in corn oil
Injection 3: 5% test substance in a 1:1 mixture FCA/corn oil
Epicutaneous: 100% test substance

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture Freunds complete adjuvant (FCA)/water
Injection 2: corn oil
Injection 3: a 1:1 mixture FCA/corn oil
Epicutaneous: corn oil

- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1 challenge
- Day of challenge: 21 (challenge)
- Exposure period: 24 h
- Test groups: 100% test substance
- Control group: 100% test substance
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h

OTHER: For the epicutaneous treatments, the test item was heated above the melting point to approx. 70 °C. The patches were soaked with the test substance and applied to the skin after cooling down. The patches were covered with a 6 x 6 cm² leukoflex-tape and fixed with an elastic bandage.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
substance residues in 4/20 animals
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: substance residues in 4/20 animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
substance residues in 1/20 animals
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: substance residues in 1/20 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
substance residues in 6/10 animals
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: substance residues in 6/10 animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
substance residues in 1/10 animals
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: substance residues in 1/10 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Local findings

- after intradermal induction: pronounced erythema and edema including slight necrosis at the FCA/water injection sites (test and control group) and the FCA/vehicle injection site (control group); pronounced erythema and edema at the test item/vehicle injection site (test group); slight erythema and edema at the vehicle injection site (control group) and pronounced erythema and edema including pronounced necrosis at the test item/FCA/vehicle injection site (test group)

- after epicutaneous induction (48 h): bloody inflammation at all sites previously treated with FCA (test group and control group); encrustation after 24 h

Body weight

No effects on body weight gain was seen during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test item showed no sensitising potential in a guinea pig maximisation test.